Product Code: FPA FDA class 2 21 CFR 880.5440

Set, Administration, Intravascular

General Hospital

The Intravascular Administration Set is a complete assembly of tubing and fittings used to deliver intravenous fluids, blood products, or medications from a container into a patient's bloodstream through an intravascular catheter. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FPA, regulated under 21 CFR 880.5440 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

1174

FEI Numbers

424

Registration Numbers

424

Unique Applicants

476

Years Active

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Basic Information

Product Code: FPA
Device Class: FDA class 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 1174 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261530	iiSure Infusion Set	Jun 03, 2026	Substantially Equivalent	Deka Research and Development
K252543	AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)	May 04, 2026	Substantially Equivalent	Amsino International, Inc.
K251375	PuraCath Firefly Needleless Connector IT (9005)	Feb 12, 2026	Substantially Equivalent	Puracath Medical, Inc.
K251257	nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]	Dec 04, 2025	Substantially Equivalent	Np Medical
K250325	BD Alaris Pump Infusion Set	Oct 30, 2025	Substantially Equivalent	Carefusion (Bd)
K251814	EZ IV Administration Set	Aug 29, 2025	Substantially Equivalent	Epic Medical Pte. , Ltd.
K251854	SteadiSet infusion set	Aug 06, 2025	Substantially Equivalent	Tandem Diabetes Care
K243841	Sparta Infusion Set for Insulin	Aug 01, 2025	Substantially Equivalent	Deka Research and Development
K243392	Infusomat® Space Volumetric Infusion Pump Administration Sets	Jul 24, 2025	Substantially Equivalent	B.Braun Medical, Inc.
K250616	Clave Neutral-Displacement Needlefree Connectors	Jun 05, 2025	Substantially Equivalent	Icu Medical, Inc.
K242692	SteadiSet Infusion Set	May 09, 2025	Substantially Equivalent	Capillary Biomedical, LLC
K242763	JetCan® Pro Safety Huber Needle	May 02, 2025	Substantially Equivalent	Pfm Medical, Inc.
K243529	Solution Administration Sets	Mar 14, 2025	Substantially Equivalent	Baxter Healthcare Corporation
K242339	Intravascular Extension Sets and Accessories	Feb 28, 2025	Substantially Equivalent	Baxter Healthcare Corporation
K241058	Lyka® PORT Needle Free Access Device (4170Y)	Dec 18, 2024	Substantially Equivalent	Quest Medical, Inc.
K234129	Ecomed Disposable Administration Sets	Sep 20, 2024	Substantially Equivalent	Ecomed Solutions, LLC
K242126	I.V. Administration Set	Aug 22, 2024	Substantially Equivalent	Bq Plus Medical Co., Ltd.
K232475	Disposable infusion set with needle	May 10, 2024	Substantially Equivalent	Shandong Zhushi Pharmaceutical Group Co., Ltd.
K222766	Disposable Extension Set	Apr 12, 2024	Substantially Equivalent	Shandong Ande Healthcare Apparatus Co., Ltd.
K232328	Insignis Syringe Infusion System	Mar 01, 2024	Substantially Equivalent	Innovative Health Sciences, LLC
K231707	ResQ Administration Set	Jan 03, 2024	Substantially Equivalent	Q For Plastic Industries
K230528	Extension Set	Dec 01, 2023	Substantially Equivalent	Medcaptain Life Science Co., Ltd.
K222780	LILY Extension Tube and Needleless Connector	Nov 09, 2023	Substantially Equivalent	Lily Medical Corporation
K230343	ProSeal Closed System Administration Set	Nov 03, 2023	Substantially Equivalent	Epic Medical Pte. , Ltd.
K221327	BD Alaris Pump Infusion Sets	Jul 21, 2023	Substantially Equivalent	Care Fusion
K221411	Surflo Winged Infusion Set	Jun 23, 2023	Substantially Equivalent	Terumo Medical Products (Hangzhou) Co., Ltd.
K221121	Volumat Polyethylene I.V. Administration Set	Jun 16, 2023	Substantially Equivalent	Fresenius Kabi
K230992	DJF Intravascular Administration Set	Jun 09, 2023	Substantially Equivalent	Yangzhou Wei DE LI Trade Co., Ltd.
K220301	Volumat Line	Jun 02, 2023	Substantially Equivalent	Fresenius Kabi
K223645	I.V. Administration Set, I.V. Extension Set	May 18, 2023	Substantially Equivalent	Bq Plus Medical Co., Ltd.
K223101	BD Secondary Infusion Set	May 12, 2023	Substantially Equivalent	Care Fusion
K220288	NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector	Apr 19, 2023	Substantially Equivalent	Np Medical, Inc.
K220312	Polyfusion IV Administration Sets	Apr 12, 2023	Substantially Equivalent	Poly Medicure Limited
K223088	BD SmartSite Needle-Free Connector	Apr 07, 2023	Substantially Equivalent	Care Fusion
K222889	FlowArt® Needle-Free Split Septum Valve	Jan 20, 2023	Substantially Equivalent	Asset Medikal Tasarim San Tic As.
K221078	Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use	Nov 21, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221075	Infusion Sets for Single Use	Nov 21, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221069	Infusion Sets for Single Use with Needles	Nov 21, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221518	NP Medical nCompass Extension Set with Stabilizing Base	Nov 03, 2022	Substantially Equivalent	Np Medical
K220267	AMSafe NeuFlo Needleless Connector	Oct 07, 2022	Substantially Equivalent	Amsino International, Inc.
K212262	PCA Syringe Sets	Oct 03, 2022	Substantially Equivalent	Baxter Healthcare Corporation
K221473	Flowart	Sep 26, 2022	Substantially Equivalent	Asset Medikal Tasarim As.
K221481	NeutrArt	Sep 23, 2022	Substantially Equivalent	Asset Medikal Tasarim As.
K213846	Q2 Blood Administration Sets	Jun 05, 2022	Substantially Equivalent	Quest Medical, Inc.
K213588	Q2 IV Administration Sets	Jun 02, 2022	Substantially Equivalent	Quest Medical, Inc.
K213004	Needle Free Connector	May 10, 2022	Substantially Equivalent	Medcaptain Life Science Co., Ltd.
K202437	Infusion Sets for Single Use	Mar 25, 2022	Substantially Equivalent	Jiangsu Suyun Medical Materials Co., Ltd.
K213778	IV Administration Set	Mar 03, 2022	Substantially Equivalent	B.Braun Medical, Inc.
K212842	Microvolume Luer Access Device	Jan 18, 2022	Substantially Equivalent	B.Braun Medical, Inc.
K213089	Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector	Nov 10, 2021	Substantially Equivalent	Ivenix, Inc.
K203609	Intravascular Administration Sets	Sep 30, 2021	Substantially Equivalent	Baxter Healthcare Corporation
K202618	IV Administration Sets	Sep 24, 2021	Substantially Equivalent	B.Braun Medical, Inc.
K210381	I.V. Administration Set	Aug 14, 2021	Substantially Equivalent	Bq Plus Medical Co., Ltd.
K202279	Insignis Subcutaneous Needle Sets	Aug 13, 2021	Substantially Equivalent	Innovative Health Sciences, LLC
K203796	Firefly Needleless Connector	Jul 30, 2021	Substantially Equivalent	Puracath Medical, Inc.
K210544	Medtronic Extended infusion set	Jul 16, 2021	Substantially Equivalent	Unomedical A/S
K210430	Intravascular Extension Set	Jun 18, 2021	Substantially Equivalent	Baxter Healthcare Corporation
K210217	Needleless Connector	May 17, 2021	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd
K201626	Safety Subcutaneous Infusion Set	Mar 24, 2021	Substantially Equivalent	Epic Medical Pte. , Ltd.
K200439	Velano ExT Extension Set	Feb 23, 2021	Substantially Equivalent	Velano Vascular
K202672	Precision Delivery Infusion Set	Jan 21, 2021	Substantially Equivalent	Quest Medical, Inc.
K201872	NeutrArt	Jan 05, 2021	Substantially Equivalent	Asset Medikal Tasarim As.
K200425	Female Luer Lock Cap	Oct 29, 2020	Substantially Equivalent	Medsafety Solutions, LLC
K193088	MaxZero Extension Sets with Needle-Free Connector(s)	Oct 23, 2020	Substantially Equivalent	Carefusion, Inc.
K200661	Steripath Micro Blood Collection System	Oct 08, 2020	Substantially Equivalent	Magnolia Medical Technologies, Inc.
K192375	Intellifuse Administration and Intellifuse Blood Administration Sets	Sep 18, 2020	Substantially Equivalent	Smiths Medical Asd, Inc.
K191640	TK Intravascular Administration Set	Aug 26, 2020	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.
K192681	Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)	Jul 28, 2020	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.
K192366	Intravascular Extension Sets and Accessories	Jul 20, 2020	Substantially Equivalent	Baxter Healthcare Corporation
K191362	LifeFlow Blood System	May 20, 2020	Substantially Equivalent	410 Medical, Inc.
K191658	IV Sets not made with PVC	Mar 19, 2020	Substantially Equivalent	B.Braun Medical, Inc.
K190806	Flowart	Feb 20, 2020	Substantially Equivalent	Asset Medikal Tasarim As.
K192647	neria guard Infusion Set	Dec 13, 2019	Substantially Equivalent	Unomedical A/S
K180739	Clearlink System Solution Set	May 28, 2019	Substantially Equivalent	Baxter Healthcare Corporation
K190233	K-Shield Advantage Port Access Infusion Set (PAIS)	May 02, 2019	Substantially Equivalent	Kawasumi Laboratories, Inc.
K180843	HIgH-Flo Super26 Subcutaneous Needle Sets	Apr 04, 2019	Substantially Equivalent	Repro-Med Systems, Inc. Dba Rms Medical Products
K182897	Velano Vascular Q2 Extension Set	Mar 26, 2019	Substantially Equivalent	Velano Vascular
K181870	Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use	Feb 26, 2019	Substantially Equivalent	Wuhan W.E.O Science & Technology Development Co., Ltd.
K182545	Tamper Evident Cap with Male Luer Lock	Jan 11, 2019	Substantially Equivalent	International Medical Industries, Inc.
K181718	BD FlowSmart Set/MiniMed Pro-Set	Oct 18, 2018	Substantially Equivalent	Becton, Dickinson and Company
K173665	AMSafe Sure-Lok Needle-Free Connector	Sep 05, 2018	Substantially Equivalent	Amsino International, Inc.
K173361	IV Administration Set	Jun 26, 2018	Substantially Equivalent	B.Braun Medical, Inc.
K173879	MiniMed Mio Advance infusion set	Mar 05, 2018	Substantially Equivalent	Unomedical A/S
K170595	IV Administration Sets	Nov 07, 2017	Substantially Equivalent	B.Braun Medical, Inc.
K162812	Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set	Nov 01, 2017	Substantially Equivalent	Unomedical A/S
K172544	IV Fat Emulsion Administration Sets	Sep 22, 2017	Substantially Equivalent	Baxter Healthcare Corporation
K170002	Medline Blood Collection Set	Sep 19, 2017	Substantially Equivalent	Medline Industries, Inc.
K171117	Carefusion NeutraClear Needle-free connector (EL-NC1000)	Sep 01, 2017	Substantially Equivalent	Cair Lgl
K171118	Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)	Aug 15, 2017	Substantially Equivalent	Cair Lgl
K171132	Carefusion NeutraClear Needle-free connector	Jul 31, 2017	Substantially Equivalent	Cair Lgl
K162951	TUBETECH IV Administration Set	Jul 28, 2017	Substantially Equivalent	Douglas Medical Products, Inc.
K171957	MaxZero Extension Sets with Needless Connector	Jul 19, 2017	Substantially Equivalent	Carefusion 303, Inc.
K161808	Solution Set with 1.2 Micron Air Eliminating Filter	Jun 21, 2017	Substantially Equivalent	Baxter Healthcare Corporation
K162826	Encore Neutral	Jun 15, 2017	Substantially Equivalent	Rymed Technologies, LLC
K171101	Closed Male Luer	Jun 02, 2017	Substantially Equivalent	Yukon Medical
K162601	Infusion Set for Single Use	May 31, 2017	Substantially Equivalent	Shinva Ande Healthcare Apparatus Co., Ltd.
K163160	Sterile Single-use Infusion Set	Apr 20, 2017	Substantially Equivalent	Jiangxi Hongda Medical Equipment Group , Ltd.
K162804	Q2 Low Pressure Power Injection Extension Set	Mar 08, 2017	Substantially Equivalent	Quest Medical, Inc.
K161898	Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set	Mar 08, 2017	Substantially Equivalent	Beijing Fert Technology Co., Ltd.
K161036	Hospira Extension Set, Hospira Primary Set	Jan 06, 2017	Substantially Equivalent	Hospira, Inc.
K160007	Paclitaxel Sets	Dec 19, 2016	Substantially Equivalent	Baxter Healthcare Corporation
K162304	Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets	Dec 06, 2016	Substantially Equivalent	Quest Medical, Inc.
K161323	Solution Set for Epidural Use	Nov 30, 2016	Substantially Equivalent	Baxter Healthcare Corporation
K153731	LifeFlow Rapid Infusion Device (LifeFlow Device)	Aug 25, 2016	Substantially Equivalent	410 Medical Innovation, LLC
K153440	PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set	Aug 18, 2016	Substantially Equivalent	C.R. Bard, Inc.
K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	Aug 10, 2016	Substantially Equivalent	Unomedical A/S
K151250	Smart Set	Jun 07, 2016	Substantially Equivalent	Top Spins, Inc.
K160870	Hospira Administration Sets	Jun 01, 2016	Substantially Equivalent	Hospira, Inc.
K150921	Orbit Infusion Set	Apr 12, 2016	Substantially Equivalent	Ypsomed AG
K160651	BD FlowSmart Set, MiniMed Pro-Set	Apr 07, 2016	Substantially Equivalent	Becton, Dickinson and Company
K153293	Extension Set	Apr 06, 2016	Substantially Equivalent	B.Braun Medical, Inc.
K151969	Hospira Extension Sets	Jan 19, 2016	Substantially Equivalent	Icu Medical, Inc.
K153158	Solution Administration Sets with 0.2 Micron Filter	Dec 28, 2015	Substantially Equivalent	Baxter Healthcare Corporation
K153257	BD FlowSmart Set, MiniMed Pro-Set	Dec 11, 2015	Substantially Equivalent	Becton, Dickinson and Company
K151079	Q2 Intravenous Adminstration Sets and Extension Sets	Sep 30, 2015	Substantially Equivalent	Quest Medical, Inc.
K151151	U & U Intravascular Administration Set	Sep 24, 2015	Substantially Equivalent	U&U Medical Technology Co, Ltd.
K143446	Accu-Chek FlexLink Plus infusion set	Aug 13, 2015	Substantially Equivalent	Roche Diagnostics GmbH
K143082	IV Administration Sets with 200(micro)m Blood Filter	Jul 24, 2015	Substantially Equivalent	B.Braun Medical, Inc.
K150513	Imed Technology Intravascular Administration Set, Imed Technology Extension Set	May 28, 2015	Substantially Equivalent	Imed Technology, Inc.
K150059	BD FlowSmart Set	Apr 28, 2015	Substantially Equivalent	Becton, Dickinson Company
K150860	Nitroglycerin Sets with DUO-VENT Spike	Apr 16, 2015	Substantially Equivalent	Baxter Healthcare Corporation
K143087	Hospira Blood Set	Mar 04, 2015	Substantially Equivalent	Hospira, Inc.
K143015	Hospira Primary Sets	Feb 25, 2015	Substantially Equivalent	Hospira, Inc.
K141285	BUSSE EXTENSION SET	Feb 19, 2015	Substantially Equivalent	Busse Hospital Disposables
K142590	All Safe Huber Safety Infusion Set	Jan 16, 2015	Substantially Equivalent	Nexus Medical, LLC
K142622	IV Administration	Jan 15, 2015	Substantially Equivalent	Hospira, Inc.
K142974	Extension Sets	Jan 09, 2015	Substantially Equivalent	Hospira, Inc.
K142433	Hospira Extension Set	Dec 08, 2014	Substantially Equivalent	Hospira, Inc.
K140838	IV ADMINISTRATION SET WITH HAND PUMP	Dec 05, 2014	Substantially Equivalent	B.Braun Medical, Inc.
K142367	Hospira Primary Sets	Nov 25, 2014	Substantially Equivalent	Hospira, Inc.
K143234	MaxZero Administration Sets	Nov 20, 2014	Substantially Equivalent	Care Fusion
K141200	PADI-LOCK	Oct 02, 2014	Substantially Equivalent	Padi-Lock, LLC
K142527	Extension Set with BD Q-Syte Luer Access Split Septum	Sep 19, 2014	Substantially Equivalent	Acacia, Inc.
K142097	SELEC-3 I.V.ADMINISTRATION SET	Aug 29, 2014	Substantially Equivalent	Biomedix, Inc.
K142036	INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS	Aug 25, 2014	Substantially Equivalent	B.Braun Medical, Inc.
K142011	SOLUTION SET/EXTENSION SET	Aug 18, 2014	Substantially Equivalent	Baxter Healthcare Corporation
K141834	SAPPHIRE ADMINISTRATION SET	Aug 05, 2014	Substantially Equivalent	Q Core Medical , Ltd.
K140175	INTRAVASCULAR ADMINISTRATION SET	Aug 05, 2014	Substantially Equivalent	Delta Med Spa
K141306	TEVADAPTOR; CONNECTING SET W/ ULTRASITE INJECTION SITE, SPIKE PORT ADAPTOR SET W/ ULTRASITE INJECTION SITE	Jun 12, 2014	Substantially Equivalent	Teva Medical Ltd., Migada Plant
K133351	NEXUS NIS-6P LUER ACTIVATED DEVICE	May 22, 2014	Substantially Equivalent	Nexus Medical, LLC
K140133	INFUSET FLOW CONTROL EXTENSION SET	May 15, 2014	Substantially Equivalent	Emed Technologies Corporation
K140311	CARESITE LUER ACCESS DEVICE	May 07, 2014	Substantially Equivalent	B.Braun Medical, Inc.
K140831	MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR	Apr 15, 2014	Substantially Equivalent	Care Fusion
K140131	SUB-Q SUBCUTANEOUS TISSUE INFUSION SET	Apr 03, 2014	Substantially Equivalent	Emed Technologies Corporation
K133073	CAIR DRIVE, NEUTRACLEAR	Mar 20, 2014	Substantially Equivalent	Cair Lgl
K133894	SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD)	Mar 18, 2014	Substantially Equivalent	Terumo Europe N.V.
K133867	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)	Feb 05, 2014	Substantially Equivalent	Terumo Europe N.V.
K132841	ZYNO MEDICAL ADMINISTRATION SET	Jan 23, 2014	Substantially Equivalent	Zyno Medical, LLC
K132880	MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE	Jan 08, 2014	Substantially Equivalent	Medical Components, Inc.
K132734	NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS	Oct 08, 2013	Substantially Equivalent	Baxter Healthcare Corp
K132142	NERIA SOFT 90 INFUSION SET	Oct 08, 2013	Substantially Equivalent	Unomedical A/S
K132413	MZ1000	Aug 29, 2013	Substantially Equivalent	Care Fusion
K130879	NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS	Jul 09, 2013	Substantially Equivalent	Nexus Medical, LLC
K130416	NEXUS TKO-6P LUER ACTIVATED DEVICE	Jun 12, 2013	Substantially Equivalent	Nexus Medical, LLC
K122404	MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26	May 06, 2013	Substantially Equivalent	Repro-Med Systems, Inc. Dba Rms Medical Products
K130023	K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR	Apr 03, 2013	Substantially Equivalent	Np Medical, Inc.
K130468	ORBIT INFUSION SET	Mar 19, 2013	Substantially Equivalent	Ypsomed AG
K123344	K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)	Mar 07, 2013	Substantially Equivalent	Kawasumi Laboratories, Inc.
K121511	MACLIN POWER INTRAVASCULAR ADMINISTRATION SET	Mar 07, 2013	Substantially Equivalent	Maclin Power, Inc.
K121269	TBA	Jan 22, 2013	Substantially Equivalent	Migada Plant
K123874	INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S	Jan 10, 2013	Substantially Equivalent	Baxter Healthcare Corp
K123868	INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET	Jan 08, 2013	Substantially Equivalent	Baxter Healthcare Corp
K123729	VERSARATE FLOW RATE CONTROLER	Dec 21, 2012	Substantially Equivalent	Emed Technologies Corporation
K121803	INTRAVASCULAR ADMINISTRATION SET	Dec 19, 2012	Substantially Equivalent	Acta Medical, LLC
K122686	ACCU-CHEK ULTRAFLEX INFUSION SET	Nov 16, 2012	Substantially Equivalent	Roche Diabetes Care AG
K113471	NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET	Oct 18, 2012	Substantially Equivalent	Nipro Medical Corporation
K113470	NIPRO SAFE TOUCH HUBER INFUSION SET	Oct 17, 2012	Substantially Equivalent	Nipro Medical Corporation
K120685	ZYNO MEDICAL ADMINISTRATION SET	Sep 07, 2012	Substantially Equivalent	Zyno Medical, LLC
K120195	SAFETY SUBCUTANEOUS TISSUE INFUSION SET	Jul 06, 2012	Substantially Equivalent	Multi Med
K121634	INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR	Jun 29, 2012	Substantially Equivalent	Baxter Healthcare Corporation
K121092	FLOWEASE [SUBCUTANEOUS] INFUSION SET	Jun 29, 2012	Substantially Equivalent	Baxter Healthcare Corp
K120375	MED-RX PATIENT DELIVERY SET	Jun 28, 2012	Substantially Equivalent	Benlan, Inc.
K121032	PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP	Jun 21, 2012	Substantially Equivalent	Hospira, Inc.
K121554	Q-FLO CLOSED MALE LUER CONNECTOR	Jun 08, 2012	Substantially Equivalent	Us Fusion, LLC. Dba Truecare Biomedix-USA
K120395	NERIA MULTI SUBCUTANEOUS INFUSION SET	May 30, 2012	Substantially Equivalent	Unomedical Devices S.A DE C.V.
K120443	NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE	May 22, 2012	Substantially Equivalent	Baxter Healthcare Corporation - Renal Division
K120548	HLIC NEEDLE-LESS VALVE	May 04, 2012	Substantially Equivalent	Health Line International Corporation
K120261	PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER	May 02, 2012	Substantially Equivalent	Perouse Medical
K120872	ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS	Apr 20, 2012	Substantially Equivalent	Unomedical A/S Infusion Devices
K113398	NEXUS TKO-6, LUER-ACTIVATED DEVICE	Apr 18, 2012	Substantially Equivalent	Nexus Medical, LLC
K112073	INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...	Apr 11, 2012	Substantially Equivalent	Rx Devices, LLC
K120799	ARISURE NEUTRAL VALVE	Mar 30, 2012	Substantially Equivalent	Yukon Medical, LLC
K113683	LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL	Jan 12, 2012	Substantially Equivalent	Hospira, Inc.
K112799	MED-RX EXTENSION SET WITH T-CONNECTOR	Dec 23, 2011	Substantially Equivalent	Benlan, Inc.
K112636	CYTOGUARD(TM) CLOSED LUER CONNECTOR	Nov 26, 2011	Substantially Equivalent	B.Braun Medical, Inc.
K112512	VANISHPOINT BLOOD COLLECTION SET	Oct 20, 2011	Substantially Equivalent	Retractable Technologies, Inc.
K112893	CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS	Oct 18, 2011	Substantially Equivalent	Baxter Healthcare Corporation
K111351	TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET	Sep 29, 2011	Substantially Equivalent	Us Infusion Dba Truecare Biomedix
K102405	INFUSION SET FOR POWERPICC SOLO 2 CATHETER	Jul 21, 2011	Substantially Equivalent	C.R. Bard, Inc.
K103562	CENTURION PRESSURE INJECTABLE EXTENSION SET	Jun 23, 2011	Substantially Equivalent	Centurion Medical Products Corporation
K111016	SAFEPORT MANIFOLD (TM) (OR STOPCOCK)	Jun 09, 2011	Substantially Equivalent	Elcam Medical Acal
K102512	RMS SUBCUTANEOUS NEEDLE SET	May 20, 2011	Substantially Equivalent	Repro-Med Systems, Inc.
K110282	LIGHTY DD INFUSION SET	Apr 27, 2011	Substantially Equivalent	Medx-Set, Ltd.
K103551	INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,	Mar 25, 2011	Substantially Equivalent	Baxter Healthcare Corp
K103224	HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING	Jan 07, 2011	Substantially Equivalent	Hospira, Inc.
K100576	HIGH PRESSURE SETS-400 PSI	Dec 17, 2010	Substantially Equivalent	Icu Medical, Inc.
K103344	INFUSION SETS	Dec 10, 2010	Substantially Equivalent	Hospira, Inc.
K101368	D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES	Nov 18, 2010	Substantially Equivalent	Dragon Heart Medical, Inc.
K100720	K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING	Nov 18, 2010	Substantially Equivalent	Kawasumi Laboratories, Inc.
K103165	BLOOD SAMPLING SET	Nov 10, 2010	Substantially Equivalent	Acacia, Inc.
K102073	MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS	Nov 08, 2010	Substantially Equivalent	Benlan, Inc.
K102890	K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)	Oct 21, 2010	Substantially Equivalent	Kawasumi Laboratories America, Inc.
K101958	AMSINO I.V. ADMINISTRATION AND EXTENSION SETS	Sep 29, 2010	Substantially Equivalent	Amsino International, Inc.
K101196	ACCU-CHEK ULTRFLEX INFUSION SET	Aug 27, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K101677	HOSPIRA INFUSION BLOOD SETS	Aug 11, 2010	Substantially Equivalent	Hospira, Inc.
K101180	GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24,	Aug 03, 2010	Substantially Equivalent	Smiths Medical MD, Inc.
K100946	INTRAVSCULAR ADMINISTRATION SET	Aug 02, 2010	Substantially Equivalent	Terumo Europe N.V.
K093489	IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY	Jul 29, 2010	Substantially Equivalent	Rymed Technologies, Inc.
K100434	CLAVE NEUTRON	Jul 09, 2010	Substantially Equivalent	Icu Medical, Inc.
K100432	POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS	Jul 09, 2010	Substantially Equivalent	Medtronic Minimed
K101385	DUAL LUER LOCK CAP, MODEL 2C6250	Jun 22, 2010	Substantially Equivalent	Baxter Healthcare Corp
K092382	NEXUS PRESSURE RATED EXTENSION SETS	Apr 26, 2010	Substantially Equivalent	Nexus Medical, LLC
K093773	AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS	Mar 10, 2010	Substantially Equivalent	Amsino International, Inc.
K092930	NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED	Mar 10, 2010	Substantially Equivalent	Nexus Medical, LLC
K092905	AUTOSTART BURETTE	Mar 04, 2010	Substantially Equivalent	Analytica Pty, Ltd.
K092527	NEXUS INJECTION SITE, MODEL NIS-8	Feb 04, 2010	Substantially Equivalent	Nexus Medical, LLC
K093271	EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD	Jan 27, 2010	Substantially Equivalent	Victus, Inc.
K092172	EXEL I.V. EXTENSION SET	Jan 04, 2010	Substantially Equivalent	Exelint Intl. Co.
K090459	DISPOSABLE TPE INFUSION SET	Oct 13, 2009	Substantially Equivalent	Shan Dong Wei Gao Group Medical Polymer Products
K090012	DISPOSABLE INFUSION SET	Jun 11, 2009	Substantially Equivalent	Shan Dong Wei Gao Group Medical Polymer Products
K083687	BAIXIN INTRAVASCULAR ADMINISTRATION SET	Jun 11, 2009	Substantially Equivalent	Anhui Kangda Medical Products Co., Ltd.
K083723	A6 LUER ACCESS DEVICE	Jun 05, 2009	Substantially Equivalent	B.Braun Medical, Inc.
K090809	MPS ACACIA POWER INJECTABLE INFUSION SET	Apr 28, 2009	Substantially Equivalent	Mps Acacia
K090134	INTRAVENOUS POWER INJECTOR EXTENSION SET	Apr 21, 2009	Substantially Equivalent	C.R. Bard, Inc.
K090189	ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE	Apr 10, 2009	Substantially Equivalent	Icu Medical, Inc.
K082806	SPINNING SPIROS, MODEL CH-2000	Apr 06, 2009	Substantially Equivalent	Icu Medical, Inc.
K083482	COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET	Apr 02, 2009	Substantially Equivalent	Cook Vascular, Inc.
K082027	FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160	Feb 13, 2009	Substantially Equivalent	Genesis Bps, LLC
K083765	MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL	Dec 30, 2008	Substantially Equivalent	Medegen Medical Manufacturing Services
K083576	MISER CONTRAST MANAGEMENT SYSTEM	Dec 23, 2008	Substantially Equivalent	Merit Medical Systems, Inc.
K082818	SUBCUTANEOUS NEEDLE INFUSION SET	Dec 23, 2008	Substantially Equivalent	Marcal Medical, Inc.
K083472	MEDEGEN PRESSURE RATED EXTENSION SETS	Dec 09, 2008	Substantially Equivalent	Medegen, Inc.
K081123	NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS	Nov 14, 2008	Substantially Equivalent	Nexus Medical, LLC
K081210	NIPRO SAFETOUCH HUBER INFUSTION SET	Oct 21, 2008	Substantially Equivalent	Nipro Medical Corp.
K082306	POWERLOC CLEAR SAFETY INFUSION SET	Aug 28, 2008	Substantially Equivalent	C.R. Bard, Inc.
K081361	CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX	Aug 28, 2008	Substantially Equivalent	Icu Medical, Inc.
K073444	TRITON MEIDCAL TMED IV-SET	Aug 18, 2008	Substantially Equivalent	Triton Medical, LLC
K080544	UNASSIGNED	Aug 14, 2008	Substantially Equivalent	Medcomp
K073396	ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG	Aug 07, 2008	Substantially Equivalent	B.Braun Medical, Inc.
K080303	EZ REGULAR	Aug 05, 2008	Substantially Equivalent	Meinntech Co., Ltd.
K081289	V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE	Aug 04, 2008	Substantially Equivalent	Baxter Healthcare Corp
K081156	CADD MEDICATION CASSETTE RESERVOIR	Jul 18, 2008	Substantially Equivalent	Smiths Medical MD, Inc.
K080695	MOBILE I.V. SYSTEMS 10,20,60	Jul 01, 2008	Substantially Equivalent	Northwind Technologies, Corp.
K080665	NOVOLET	May 13, 2008	Substantially Equivalent	U.S. Safety Syringes Co., Inc.
K080660	IV ADMINISTRATION SET	May 13, 2008	Substantially Equivalent	U.S. Safety Syringes Co., Inc.
K073050	SAFESTEP MAX POWER-INJECTABLE INFUSION SET	Jan 25, 2008	Substantially Equivalent	Specialized Health Products International, Inc.
K072375	SMARTPORT CT MP PORT ACCESS SYSTEM AND LIFEGUARD CT SAFETY INFUSION SET	Dec 13, 2007	Substantially Equivalent	AngioDynamics, Inc.
K072894	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)	Nov 06, 2007	Substantially Equivalent	Terumo Europe N.V.
K072576	CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED	Nov 06, 2007	Substantially Equivalent	Baxter Healthcare Corp
K063631	POLYPERF / POLYPERF SAFE	Oct 05, 2007	Substantially Equivalent	Laboratoires Perouse
K071421	PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET	Oct 04, 2007	Substantially Equivalent	Promepla
K072542	MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR	Sep 25, 2007	Substantially Equivalent	Medegen Medical Manufacturing System
K070630	HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE	Aug 31, 2007	Substantially Equivalent	Health Line International Corporation (Hlic)
K071846	MODIFICATION TO EZ HUBER SAFETY INFUSION SET	Aug 30, 2007	Substantially Equivalent	Pfm Medical, Inc.
K070547	SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SURSHIELD)	May 25, 2007	Substantially Equivalent	Terumo Europe N.V.
K070801	IMM HYPODERMIC NEEDLE SET	May 24, 2007	Substantially Equivalent	Innovative Medical Manufacturing Co.
K070362	SURFLO WINGED INFUSION SET	May 07, 2007	Substantially Equivalent	Terumo Europe N.V.
K070430	PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS	Apr 04, 2007	Substantially Equivalent	Unomedical A/S
K070532	SPIROS	Mar 20, 2007	Substantially Equivalent	Icu Medical, Inc.
K062308	LMT-KATH-S; LMT-KATH-I	Mar 20, 2007	Substantially Equivalent	Licher Medizintechnologie GmbH
K062909	REPEATER PUMP II TUBE SETS	Mar 09, 2007	Substantially Equivalent	Baxa Corp.
K070189	ACCU-CHEK ULTRAFLEX INFUSION SET	Feb 21, 2007	Substantially Equivalent	Disetronic Medical Systems AG
K061374	INTUITION INFUSION SETS	Jul 31, 2006	Substantially Equivalent	Unomedical A/S
K061285	SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS	Jul 26, 2006	Substantially Equivalent	Cardinal Health, Alaris Products
K061771	EZ-CONNECT	Jul 10, 2006	Substantially Equivalent	Vidacare Corporation
K061115	SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216	Jun 30, 2006	Substantially Equivalent	Gvs Spa
K060488	DERMATECH IV HOLDER	Jun 08, 2006	Substantially Equivalent	Dermatech Medical, Inc.
K060580	K-SHIELD PORT ACCESS INFUSION SET	Jun 06, 2006	Substantially Equivalent	Kawasumi Laboratories, Inc.
K060352	HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS	May 31, 2006	Substantially Equivalent	Health Line International Corporation
K060672	ONE STICK Y EXTENSION SET AND VOLUMETER	Mar 31, 2006	Substantially Equivalent	One Stick, LLC
K060082	TIANJIN MEDIS DISPOSABLE INFUSION SET	Mar 31, 2006	Substantially Equivalent	Tianjin Medis International Trade Co., Ltd.
K060074	INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326	Mar 29, 2006	Substantially Equivalent	Baxter Healthcare Corp
K053049	ALARIS SAFETY MALE LUER	Jan 12, 2006	Substantially Equivalent	Cardinal Health, Alaris Products
K053106	TEGO, MODEL D1000	Jan 10, 2006	Substantially Equivalent	Icu Medical, Inc.
K053129	NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5	Dec 08, 2005	Substantially Equivalent	Nexus Medical, LLC
K052887	SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS	Dec 08, 2005	Substantially Equivalent	Terumo Europe N.V.
K052432	MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2	Nov 29, 2005	Substantially Equivalent	Medtronic Minimed
K052252	CONTRAST MEDIA TRANSFER SETS	Nov 16, 2005	Substantially Equivalent	B.Braun Medical, Inc.
K052722	LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS	Nov 02, 2005	Unknown	Hospira, Inc.
K052658	SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET	Oct 12, 2005	Substantially Equivalent	Renascence Medical, Inc.
K051943	SUREFLOW SAFETY INFUSION DEVICE	Oct 04, 2005	Substantially Equivalent	Intrasafe Medical, LLC
K051264	COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS	Sep 01, 2005	Substantially Equivalent	Unomedical A/S
K050906	VITALCARE I.V. ADMINISTRATION SET	Aug 23, 2005	Substantially Equivalent	Vitalcare Group, Inc.
K051437	CML 1000	Aug 03, 2005	Substantially Equivalent	Icu Medical, Inc.
K051939	MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR	Aug 01, 2005	Substantially Equivalent	Medegen Medical Manufacturing System
K051142	ANGIODYNAMICS TUMESCENT INFUSION DEVICE	Jul 13, 2005	Substantially Equivalent	AngioDynamics, Inc.
K051009	HUBER CLEAR SAFETY INFUSION SET	Jul 12, 2005	Substantially Equivalent	Now Medical Distribution, Inc.
K051499	INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET	Jun 22, 2005	Substantially Equivalent	Medegen Medical Manufacturing Services
K050600	MINILOC SAFETY INFUSION SET	May 12, 2005	Substantially Equivalent	Specialized Health Products, Intl.
K043328	MICROFLO-SAFE SCALP VEIN SET	Apr 15, 2005	Substantially Equivalent	Dks Loversan Industria Biomedica Spa
K041495	PENTADEFLUE IV SOLUTION ADMINISTRATION SETS	Apr 15, 2005	Substantially Equivalent	Pentaferte S.P.A
K050207	BD POSIFLOW POSITIVE DISPLACEMENT VALVE	Apr 07, 2005	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K043235	DRAGON HEART I.V. SET	Mar 08, 2005	Substantially Equivalent	Dragon Heart Medical Devices Co., Ltd.
K042129	F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY SET WITH MALE LUER LOCK	Jan 27, 2005	Substantially Equivalent	Cedic S.R.L.
K042666	LUTH-ALL SUB-Q NEEDLE SET	Dec 21, 2004	Substantially Equivalent	Luth-All Medical Products, LLC
K042936	SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE	Nov 26, 2004	Substantially Equivalent	Baxter Healthcare Corp
K041861	NEXUS INTRAVENOUS TUBING SETS (NIVTS)	Nov 26, 2004	Substantially Equivalent	Nexus Medical, LLC
K041490	IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING	Oct 29, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K042693	IV ADMINISTRATION SET B400 SP	Oct 21, 2004	Substantially Equivalent	Codan US Corp.
K042172	CLEO 90 INFUSION SET	Oct 07, 2004	Substantially Equivalent	Smiths Medical MD, Inc.
K041919	PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606	Oct 04, 2004	Substantially Equivalent	Clinico
K040533	EZ HUBER SAFETY INFUSION SET	Sep 17, 2004	Substantially Equivalent	Pfm Medical, Inc.
K042234	MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET	Sep 08, 2004	Substantially Equivalent	Specialty Health Products, Inc.
K041844	ALL SAFE HUBER SAFETY INFUSION SETS	Sep 03, 2004	Substantially Equivalent	Nexus Medical, LLC
K042182	Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432	Sep 01, 2004	Substantially Equivalent	Icu Medical, Inc.
K041845	NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4	Aug 24, 2004	Substantially Equivalent	Nexus Medical, LLC
K040710	TEGO NEEDLE FREE ACCESS ACCESS DEVICE	Aug 11, 2004	Substantially Equivalent	Icu Medical, Inc.
K041410	PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118	Jul 28, 2004	Substantially Equivalent	Icu Medical, Inc.
K041042	SPLIT SEPTUM INJECTION SITES	Jul 16, 2004	Substantially Equivalent	Fresenius Medical Care North America
K041545	CONTACT DETACH	Jun 30, 2004	Substantially Equivalent	Unomedical A/S
K041179	MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR	Jun 04, 2004	Substantially Equivalent	Medegen Medical Manufacturing Services, Inc.
K032767	LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES	Jun 03, 2004	Substantially Equivalent	Lily Medical Supplies Co., Ltd.
K040636	CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET	May 19, 2004	Substantially Equivalent	Smiths Medical MD, Inc.
K033290	TALON INFUSION SET, MODEL IP XXXX	Apr 12, 2004	Substantially Equivalent	Icu Medical, Inc.
K040385	MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900	Apr 07, 2004	Substantially Equivalent	Quest Medical, Inc.
K040633	CLICK-ON	Apr 01, 2004	Substantially Equivalent	Unomedical A/S
K040527	LOW PROFILE LUTHER SAFETY HUBER	Mar 26, 2004	Substantially Equivalent	Luther Needlesafe Products, Inc.
K033208	IVY DEVICES INC. IV/MEDICAL LINE STABILIZER	Mar 18, 2004	Substantially Equivalent	Ivy Devices, Inc.
K033892	ULTRAFLEX INFUSION SET	Mar 09, 2004	Substantially Equivalent	Disetronic Medical Systems AG
K033301	IV ADMINISTRATION AND CONNECT SETS	Mar 04, 2004	Substantially Equivalent	Codan US Corp.
K033515	HUBERPRO SAFETY HUBER INFUSION SET	Jan 22, 2004	Substantially Equivalent	Command Medical Products
K033576	LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE	Dec 04, 2003	Substantially Equivalent	Abbott Laboratories
K021692	CLC2000 CATHETER PATENCY DEVICE	Dec 04, 2003	Substantially Equivalent	Icu Medical, Inc.
K033350	BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER	Nov 18, 2003	Substantially Equivalent	Becton, Dickinson & CO
K032934	MPS ACACIA SAFEGUARD HUBER DEVICE	Nov 13, 2003	Substantially Equivalent	Mps Acacia
K032485	MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313	Oct 28, 2003	Substantially Equivalent	Medtronic Minimed
K032484	MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310	Oct 28, 2003	Substantially Equivalent	Medtronic Minimed
K033099	ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109	Oct 16, 2003	Substantially Equivalent	Applied Diabetes Research, Incorporated
K032854	UNOMEDICAL MONICA INFUSION SET	Oct 09, 2003	Substantially Equivalent	Unomedical A/S
K032150	SAFETY-MULTIFLY	Sep 12, 2003	Substantially Equivalent	Sarstedt, Inc.
K021471	MARQUETTE HUBER TRAP SAFETY INFUSION SET	Sep 08, 2003	Substantially Equivalent	Marquette Medical, Inc.
K020424	V SET	Aug 29, 2003	Substantially Equivalent	Hennig Enterprises Europe Srl
K020419	V SET	Aug 29, 2003	Substantially Equivalent	P.T. Greenleaf
K031917	MEDTRONIC MINIMED PARADIGM POLYFIN QR, MODEL MMT 312L AND 312S	Aug 19, 2003	Substantially Equivalent	Medtronic Minimed
K031923	ULTRASITE VALVE	Aug 11, 2003	Substantially Equivalent	B.Braun Medical, Inc.
K031500	EXCEL PRIMARY SOLUTION SET	Jul 25, 2003	Substantially Equivalent	Exelint Intl. Co.
K031783	SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005	Jul 01, 2003	Substantially Equivalent	Intravascular Incorporated
K023668	JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR	Jul 01, 2003	Substantially Equivalent	Jms North America Corp.
K031279	SURSHIELD SAFETY WINGED BLOOD COLLECTION SET	May 30, 2003	Substantially Equivalent	Terumo Medical Products Hangzhou Co., Ltd.
K031266	SURSHIELD SAFETY WINGED INFUSION SET	May 30, 2003	Substantially Equivalent	Terumo Corp.
K031361	CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP	May 23, 2003	Substantially Equivalent	Deltec, Inc.
K030385	IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR	Apr 15, 2003	Substantially Equivalent	Kawasumi Laboratories America, Inc.
K020189	EXEL BUTTERFLY SCALP VEIN SET	Mar 27, 2003	Substantially Equivalent	Exelint International, Co.
K030149	MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9	Mar 20, 2003	Substantially Equivalent	Avail Medical Products, Inc.
K030467	GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET	Mar 14, 2003	Substantially Equivalent	Iv Medical, Inc.
K030246	VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072	Feb 26, 2003	Substantially Equivalent	Victus, Inc.
K023917	WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR	Feb 26, 2003	Substantially Equivalent	Kawasumi Laboratories, Inc.
K030137	MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9	Feb 19, 2003	Substantially Equivalent	Avail Medical Products, Inc.
K024363	NEXUS INJECTION SITE (NIS), MODEL NIS-1	Feb 19, 2003	Substantially Equivalent	Nexus Medical, LLC
K030002	LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.	Jan 27, 2003	Substantially Equivalent	Abbott Laboratories
K023769	PREPARE ADMINISTRATION SET	Dec 30, 2002	Substantially Equivalent	Appro Healthcare, Inc.
K023595	BURETTE-IN LINE (150 ML)	Dec 18, 2002	Substantially Equivalent	Tuta Healthcare Pty Limited
K023469	VICTUS I.V. ADMINISTRATION SET, MODELS 27058, 27059,27062	Dec 10, 2002	Substantially Equivalent	Victus, Inc.
K020533	EXEL VACULET BLOOD COLLECTION SET	Dec 02, 2002	Substantially Equivalent	Exelint Intl. Co.
K023585	FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000	Nov 21, 2002	Substantially Equivalent	Intravascular Incorporated
K021565	LUTHER SAFETY HUBER NEEDLE SET	Nov 14, 2002	Substantially Equivalent	Luther Research Partners
K021916	HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001	Aug 29, 2002	Substantially Equivalent	Harmac Medical Products, Inc.
K021080	NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS	Aug 29, 2002	Substantially Equivalent	Cardio Med Supplies, Inc.
K021999	GRIPPER PLUS NEEDLE	Aug 13, 2002	Substantially Equivalent	Deltec, Inc.
K022209	ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS	Aug 06, 2002	Substantially Equivalent	Alaris Medical Systems, Inc.
K020926	EXTENSION SET, MODELS 1911-512	Jul 12, 2002	Substantially Equivalent	Epimed International, Inc.
K021488	SURECAN SAFETY HUBER NEEDLE INFUSION SETS	Jul 08, 2002	Substantially Equivalent	B.Braun Medical, Inc.
K021480	EXTENSION SET LIGHT-SAFE, MODEL BC565	Jun 27, 2002	Substantially Equivalent	Codan US Corp.
K021530	SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN	May 21, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K021487	SIMPLICITY EASY ACCESS P INFUSION SET	May 17, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K021296	SIMPLICITY QD EASY P INFUSION SET	May 14, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K021395	MODIFICATION TO 30 EXTENSION SET	May 13, 2002	Substantially Equivalent	Churchill Medical Systems, Inc.
K021216	SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS	May 03, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K020530	EVANS SUB-Q, MODEL MC4206	Apr 29, 2002	Substantially Equivalent	Evans Medical, Inc.
K021005	SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE	Apr 25, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K013621	BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100	Apr 16, 2002	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K020990	SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN	Apr 10, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K020912	SIMPLICITY EASY SOFT INFUSION SET	Apr 10, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K020629	SIMPLICITY SIMPLEX SOFT INFUSION SET	Apr 01, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K013871	LIFEGUARD SAFETY INFUSION SET	Mar 29, 2002	Substantially Equivalent	Horizon Medical Products, Inc.
K013714	CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP	Mar 28, 2002	Substantially Equivalent	Codan US Corp.
K013949	UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR	Mar 27, 2002	Substantially Equivalent	Churchill Medical Systems, Inc.
K020544	WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA	Mar 12, 2002	Substantially Equivalent	Churchill Medical Systems, Inc.
K014062	SIMPLICITY EASY ACCESS INFUSION SET	Jan 17, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K014061	SIMPLICITY STARPLUS SOFT INFUSION SET	Jan 17, 2002	Substantially Equivalent	Sterling Medivations, Inc.
K012879	EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE	Jan 17, 2002	Substantially Equivalent	Exelint Intl. Co.
K013950	VENTED VIAL ACCESS DEVICE	Jan 10, 2002	Substantially Equivalent	Churchill Medical Systems, Inc.
K013502	SIMPLICITY CLASSIC WING QD INFUSION SET	Dec 03, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K013394	LIFTLOC SAFETY INFUSION SET	Nov 08, 2001	Substantially Equivalent	Specialized Health Products, Inc.
K012429	SURESET INFUSION SET, MODEL 8023	Nov 06, 2001	Substantially Equivalent	Applied Diabetes Research, Incorporated
K013164	SURSHIELD SAFETY WINGED BLOOD COLLECTION SET	Oct 15, 2001	Substantially Equivalent	Terumo Medical Corp.
K013104	SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE	Oct 02, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K011405	EXEL INJECTION PLUG WITH CAP	Sep 27, 2001	Substantially Equivalent	Exelint Intl. Co.
K012845	SIMPLICITY SOFT QD MICRO INFUSION SET	Sep 14, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K012526	BIOTEQUE SCALP VEIN SET	Sep 14, 2001	Substantially Equivalent	Bioteque Corp.
K011888	PRESSURE ACTIVATED CHECK VALVE	Sep 10, 2001	Substantially Equivalent	Churchill Medical Systems, Inc.
K010404	EXEL I.V. ADMINISTRATION SET	Aug 30, 2001	Substantially Equivalent	Exelint Intl. Co.
K012754	EZ SET INFUSION SET	Aug 27, 2001	Substantially Equivalent	Animas Corp.
K012330	SIMPLICITY EURO QD INFUSION SET	Aug 10, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K011928	HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05	Aug 10, 2001	Substantially Equivalent	Northgate Technologies, Inc.
K011216	PVC FREE INTRAVASCULAR ADMINISTRATION SET	Jul 18, 2001	Substantially Equivalent	Biometrix , Ltd.
K003254	CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001	Jul 09, 2001	Substantially Equivalent	Mission Medicl Devices
K010888	SIDEPORT PINCH CLAMP DEVICE	Jun 27, 2001	Substantially Equivalent	Medivice Systems, Ltd.
K011858	INTERLINK THREADED LOCK CANNULA	Jun 19, 2001	Substantially Equivalent	Bd
K011187	SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS	Jun 19, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K011336	PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK	Jun 12, 2001	Substantially Equivalent	Churchill Medical Systems, Inc.
K011193	NAC PLUS NEEDLELESS ACCESS CONNECTOR	Jun 12, 2001	Substantially Equivalent	Porex Medical Products
K011071	PARADIGM QUICK-SET INFUSION SET	Jun 07, 2001	Substantially Equivalent	Maersk Medical A/S
K011580	SIMPLICITY SOFT QD SILVER INFUSION SET	Jun 05, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K010279	MEDISYSTEMS LUER ACCESS INJECTION SITE	May 29, 2001	Substantially Equivalent	Medisystems Corp.
K010197	EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET	May 14, 2001	Substantially Equivalent	Exelint International, Co.
K011120	GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES	May 08, 2001	Substantially Equivalent	Nipro Diabetes Systems, Inc.
K010886	SIMPLICITY WING INFUSION SET	Apr 30, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K011003	SAFESTING AND SAFESTING HUB	Apr 20, 2001	Substantially Equivalent	Diasol, Inc.
K010788	SIMPLICITY SOFT QD EASY INFUSION SET	Apr 20, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K010676	SIMPLICITY WINGED QD INFUSION SET	Apr 18, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K010647	SIMPLICITY INFUSER INFUSION SET	Apr 13, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K010846	SIMPLICITY SILVER SET SOFT INFUSION	Apr 12, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K000592	UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET	Apr 12, 2001	Substantially Equivalent	Myco Medical Supplies, Inc.
K010538	PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E	Mar 30, 2001	Substantially Equivalent	Rd Medical Mfg., Inc.
K010103	SURSHIELD WINGED INFUSION SET	Mar 15, 2001	Substantially Equivalent	Terumo Medical Corp.
K010373	SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)	Mar 13, 2001	Substantially Equivalent	Sterling Medivations, Inc.
K002689	SWABSITE SWABBABLE VALVE, MODEL 245000	Mar 06, 2001	Substantially Equivalent	Quest Medical, Inc.
K003977	DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET	Feb 15, 2001	Substantially Equivalent	Disetronic Medical Systems AG
K001329	INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET	Feb 14, 2001	Substantially Equivalent	Lifemed of California
K003854	INTRAVASCULAR ADMINISTRATION SET	Feb 05, 2001	Substantially Equivalent	Infusion Devices, Inc.
K003513	TAXOL ADMINISTRATION SET	Jan 11, 2001	Substantially Equivalent	Icu Medical, Inc.
K002449	BIOTEQ I.V. (INTRAVENOUS) SET	Dec 22, 2000	Substantially Equivalent	Bioteque Corp.
K003283	SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)	Dec 13, 2000	Substantially Equivalent	Sterling Medivations, Inc.
K001233	ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S	Dec 13, 2000	Substantially Equivalent	R-Group Intl.
K002492	SIMPLICITY SOFT INFUSION SET	Oct 24, 2000	Substantially Equivalent	Sterling Medivations, Inc.
K003225	SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE	Oct 19, 2000	Substantially Equivalent	Baxter Healthcare Corp
K002471	JETCAN HUBER NEEEDLE SET	Oct 19, 2000	Substantially Equivalent	Pfm Produkte Fur Die Medizin AG
K001599	ACTI-FLEX IV ADMINISTRATION SET	Sep 18, 2000	Substantially Equivalent	R-Group Intl.
K001872	I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411	Sep 07, 2000	Substantially Equivalent	Codan US Corp.
K002138	PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380	Aug 29, 2000	Substantially Equivalent	Maersk Medical A/S
K001832	PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318	Aug 18, 2000	Substantially Equivalent	Minimed, Inc.
K001827	PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325	Aug 18, 2000	Substantially Equivalent	Minimed, Inc.
K001106	MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000	Aug 16, 2000	Substantially Equivalent	Creative Plastic Technology
K002006	LIFESHIELD ADDITIVE PIERCING PIN	Aug 10, 2000	Substantially Equivalent	Abbott Laboratories
K001426	KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER	Jul 21, 2000	Substantially Equivalent	Kawasumi Laboratories America, Inc.
K001424	KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD	Jul 21, 2000	Substantially Equivalent	Kawasumi Laboratories America, Inc.
K001423	KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY	Jul 21, 2000	Substantially Equivalent	Kawasumi Laboratories America, Inc.
K990331	SURGEN VALVE	May 31, 2000	Substantially Equivalent	Tiva Medical
K000472	POSI-LINK	May 10, 2000	Substantially Equivalent	Icu Medical, Inc.
K000942	CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090	Apr 27, 2000	Substantially Equivalent	Sims Deltec, Inc.
K001102	PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E	Apr 20, 2000	Substantially Equivalent	Rd Medical Mfg., Inc.
K994429	VENUSA, LTD. EXTENSION SET WITH FILTER	Mar 03, 2000	Substantially Equivalent	Venusa , Ltd.
K000343	NAC Y-ADP	Mar 01, 2000	Substantially Equivalent	The Kipp Group
K000152	KIPPMED I.V. MANIFOLD	Feb 29, 2000	Substantially Equivalent	The Kipp Group
K992290	EXEL INJECTION PLUG WITH CAP	Feb 23, 2000	Substantially Equivalent	Exel Intl.
K000017	PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400	Feb 10, 2000	Substantially Equivalent	Rd Medical Mfg., Inc.
K993848	MILLENNIUM HUBER PLUS SAFETY INFUSION SET	Jan 27, 2000	Substantially Equivalent	Millennium Medical Distribution, Inc.
K993463	INTRAVASCULAR ADMINISTRATION SET	Jan 04, 2000	Substantially Equivalent	Custom Assemblies, Inc.
K993187	SHELLY PROTECTED AV FISTULA NEEDLE	Nov 05, 1999	Substantially Equivalent	Diasol, Inc.
K992999	DAISY PROTECTED SCALP VEIN SET	Nov 05, 1999	Substantially Equivalent	Diasol, Inc.
K993147	DECAP	Nov 02, 1999	Substantially Equivalent	The Kipp Group
K992266	IV ADMINISTRATION SET	Oct 27, 1999	Substantially Equivalent	New Alliance of Independent Medical Distributors,
K992145	ECOMED SCALP VEIN SET	Oct 14, 1999	Substantially Equivalent	Greiner Meditech, Inc.
K992268	NAC PRN NEEDLELESS ACCESS CONNECTOR	Sep 15, 1999	Substantially Equivalent	The Kipp Group
K992072	BOLUS ACCESSORY SET	Sep 15, 1999	Substantially Equivalent	I-Flow Corp.
K991979	SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321	Sep 03, 1999	Substantially Equivalent	Medtronic Minimed
K991112	SAGE CONTRAST MANAGEMENT SYSTEM	Sep 02, 1999	Substantially Equivalent	Sage Laboratories, Inc.
K990777	MED-RX EXTENSION SETS	Aug 25, 1999	Substantially Equivalent	Benlan, Inc.
K992104	PARSET, MODEL A10001E	Aug 23, 1999	Substantially Equivalent	Rd Medical Mfg., Inc.
K991985	COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET	Aug 20, 1999	Substantially Equivalent	Cook, Inc.
K991932	INTRAVASCULAR ADMINISTRATION SET	Aug 20, 1999	Substantially Equivalent	The Kipp Group
K984569	AB2 MED-FLO SOLUTION SET	Aug 12, 1999	Substantially Equivalent	Ab2 Medical Products, Llp
K984060	LUER ACCESS INJECTION SITE	Jul 26, 1999	Substantially Equivalent	Baxter Healthcare Corp
K990496	ANESFLOW-DUAL DRIP IV INFUSION SET	Jul 01, 1999	Substantially Equivalent	Innovative Design Assoc.
K991759	MAERSK MEDICAL CONTOUR INFUSION SET	Jun 25, 1999	Substantially Equivalent	Maersk Medical A/S
K991653	INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM	Jun 24, 1999	Substantially Equivalent	Rymed Technologies, Inc.
K991513	HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO	Jun 21, 1999	Substantially Equivalent	I-Flow Corp.
K991599	CADD ADMINISTRATION SET	Jun 15, 1999	Substantially Equivalent	Sims Deltec, Inc.
K991301	CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1	Jun 09, 1999	Substantially Equivalent	Sims Deltec, Inc.
K991255	CADD-TPN ADMINISTRATION SET, MODEL 21-7071	Jun 09, 1999	Substantially Equivalent	Sims Deltec, Inc.
K990693	FLEXNEEDLE PLUS	May 14, 1999	Substantially Equivalent	Act Medical, Inc.
K990388	TUTOPLUS IV ADMINISTRATION SET	Mar 29, 1999	Substantially Equivalent	Myco Medical Supplies, Inc.
K982098	TUTODROP 1 AND TUTODROP 2	Mar 01, 1999	Substantially Equivalent	Myco Medical Supplies, Inc.
K990288	FREE FLOW SAFETY DEVICE, MODEL MG 245052	Feb 24, 1999	Substantially Equivalent	Teva Medical, Ltd.
K984441	KVO CHECK VALVE ACCESSORY, MODEL EV-0001	Feb 22, 1999	Substantially Equivalent	I-Flow Corp.
K984381	BURETROL SOLUTION SETS	Feb 19, 1999	Substantially Equivalent	Baxter Healthcare Corp
K990083	CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER	Feb 12, 1999	Substantially Equivalent	Sims Deltec, Inc.
K984638	PARAGON BOLUS ACCESSORY SET	Feb 09, 1999	Substantially Equivalent	I-Flow Corp.
K984146	PARAGON INFUSION	Feb 09, 1999	Substantially Equivalent	I-Flow Corp.
K984063	PARAGON BASAL/BOLUS ADMINISTRATION SET	Feb 09, 1999	Substantially Equivalent	I-Flow Corp.
K983411	COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105	Feb 09, 1999	Substantially Equivalent	Valnet Medical Corp.
K984561	SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B	Feb 04, 1999	Substantially Equivalent	Msr, Inc.
K983926	MPS GRAVITY FLOW CONTROL SET	Jan 20, 1999	Substantially Equivalent	Critical Device Corp.
K983217	ROWE DUAL-CHECK VALVE	Jan 20, 1999	Substantially Equivalent	Cook, Inc.
K983073	I.V. EXTENSION SET OR I.V. ADMINISTRATION SET	Dec 16, 1998	Substantially Equivalent	Integra Biotechnical, LLC
K982672	COLLEAGUE PUMP SYRINGE ADAPTER SET	Sep 04, 1998	Substantially Equivalent	Baxter Healthcare Corp
K982587	MPS FIXED FLOW RATE SET	Aug 24, 1998	Substantially Equivalent	Medical Product Specialists
K981792	SOLUTION ADMINISTRATION SET	Aug 17, 1998	Substantially Equivalent	Baxter Healthcare Corp
K981683	HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y	Jul 28, 1998	Substantially Equivalent	Venusa , Ltd.
K982123	CONTRAST CONTROL DEVICE	Jul 21, 1998	Substantially Equivalent	Medex, Inc.
K982047	MPS HUBER NEEDLE EXTENSION SET	Jul 21, 1998	Substantially Equivalent	Medical Product Specialists
K981386	MANAN BLUNT NEEDLE	Jun 29, 1998	Substantially Equivalent	Manan Medical Products, Inc.
K981548	NFC NEEDLEFREE CONNECTOR MODEL 69900	Jun 18, 1998	Substantially Equivalent	Filtertek, Inc.
K981547	NFC NEEDLEFREE Y-SITE, MODEL 69970	Jun 18, 1998	Substantially Equivalent	Filtertek, Inc.
K981157	STABLE FLOW	Jun 16, 1998	Substantially Equivalent	Cmed
K980994	IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES	May 29, 1998	Substantially Equivalent	Venetec Intl., Inc.
K980992	IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES	May 28, 1998	Substantially Equivalent	Venetec Intl., Inc.
K974571	SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE	May 21, 1998	Substantially Equivalent	Baxter Healthcare Corp
K980583	EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE	Apr 27, 1998	Substantially Equivalent	Sims Deltec, Inc.
K981318	DUAL LUER LOCK CAP	Apr 22, 1998	Substantially Equivalent	Baxter Healthcare Corp
K980127	6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT	Mar 11, 1998	Substantially Equivalent	Catheter Innovations, Inc.
K973916	NP MEDICAL CAPLESS LUER ACTIVATED VALVE	Mar 09, 1998	Substantially Equivalent	Np Medical, Inc.
K974163	MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316	Feb 02, 1998	Substantially Equivalent	Medtronic Minimed
K971844	MCKINLEY OUTBOUND-2 SYSTEM	Jan 23, 1998	Substantially Equivalent	Mckinley, Inc.
K974589	SMARTVALVE	Jan 09, 1998	Substantially Equivalent	Icu Medical, Inc.
K974145	V3 VALVE	Jan 06, 1998	Substantially Equivalent	B.Braun Medical, Inc.
K974013	EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE	Dec 17, 1997	Substantially Equivalent	Sims Deltec, Inc.
K972854	PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY	Dec 17, 1997	Substantially Equivalent	Globe Ent., Inc.
K972839	PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET	Dec 17, 1997	Substantially Equivalent	Globe Ent., Inc.
K963659	EXEL I.V. ADMINISTRATION SET	Dec 16, 1997	Substantially Equivalent	Exel Intl.
K973167	POSITIVE PRESSURE CONNECTOR	Nov 17, 1997	Substantially Equivalent	Icu Medical, Inc.
K973107	AMSINO I.V. ADMINISTRATION SET	Oct 02, 1997	Substantially Equivalent	Amsino Intl., Inc.
K971004	MEDCORP FLOW I.V. REGULATOR EXTENSION SET	Oct 02, 1997	Substantially Equivalent	Medcorp Intl.
K972712	CORE RESISTANT HUBER INFUSION SETS	Oct 01, 1997	Substantially Equivalent	Icu Medical, Inc.
K972957	SA-EF MULTI-LUMEN EXTENSION SET	Sep 29, 1997	Substantially Equivalent	Vlv Associates, Inc.
K972527	PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS	Sep 18, 1997	Substantially Equivalent	Quality System Consulting
K972493	NIPRO DISPOSABLE SOLUTION INFUSION SET	Sep 18, 1997	Substantially Equivalent	Nipro Medical Corp.
K971624	DYE STOP AND SAVE - QUICKFILL	Sep 08, 1997	Substantially Equivalent	Shepherd Laboratories, Inc.
K972663	SMART SET	Sep 02, 1997	Substantially Equivalent	Top Spins, Inc.
K972135	MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET	Aug 26, 1997	Substantially Equivalent	P/L Biomedical
K971500	ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER	Aug 18, 1997	Substantially Equivalent	Biological & Environmental Control Laboratories
K964439	NEEDLE-FREE VALVED CONNECTOR AND CAP	Jul 16, 1997	Substantially Equivalent	Bmw Medical, Inc.
K971293	LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE	Jun 27, 1997	Substantially Equivalent	Abbott Mfg., Inc.
K970855	CLAVE CONNECTOR	Jun 24, 1997	Substantially Equivalent	Icu Medical, Inc.
K965027	VENTED I.V. SET	Jun 24, 1997	Substantially Equivalent	Jms Co., Ltd.
K971701	CONTINU-FLO SOLUTION SET	Jun 06, 1997	Substantially Equivalent	Baxter Healthcare Corp
K964067	GORE IRRIGATION SET	Jun 05, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K971066	TAMARYN I.V. FLOW REGULATOR EXTENSION SET	Jun 04, 1997	Substantially Equivalent	Tamaryn Medical Systems, Inc.
K970909	SAFE-CONNECT I.V. SET	May 06, 1997	Substantially Equivalent	Faulding Medical Device Co.
K971266	SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518	May 01, 1997	Substantially Equivalent	Faulding Medical Device Co.
K970524	SAFE-CONNECT I.V. EXTENSION SET	Apr 22, 1997	Substantially Equivalent	Faulding Medical Device Co.
K970485	SMARTSITE ACCESS PIN	Apr 21, 1997	Substantially Equivalent	Ivac Medical Systems
K970255	KIPP MED I.V. MANIFOLD	Apr 14, 1997	Substantially Equivalent	The Kipp Group
K964918	NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS	Apr 14, 1997	Substantially Equivalent	Critical Device Corp.
K970259	E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET	Apr 08, 1997	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K970800	MAXCESS NEEDLEFREE - Y- SITE (100713)	Apr 02, 1997	Substantially Equivalent	Solopak Medical Products, Inc.
K970438	INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS	Apr 02, 1997	Substantially Equivalent	Baxter Healthcare Corp
K970076	NIPRO DISPOSABLE SOLUTION INFUSION SET	Mar 27, 1997	Substantially Equivalent	Nipro Medical Corp.
K964844	CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS	Mar 24, 1997	Substantially Equivalent	Conmedcorp
K964876	SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET	Feb 28, 1997	Substantially Equivalent	Vlv Associates, Inc.
K964968	MR EXTENSION SET (001)	Feb 27, 1997	Substantially Equivalent	University of Michigan
K964850	SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER	Feb 25, 1997	Substantially Equivalent	Baxter Healthcare Corp
K963981	VYGON BIONECTOR WITH EXTENSION SET	Feb 14, 1997	Substantially Equivalent	Vygon Corp.
K964812	NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET	Feb 10, 1997	Substantially Equivalent	Critical Device Corp.
K964456	POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367	Jan 30, 1997	Substantially Equivalent	Medtronic Minimed
K964455	POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333	Jan 30, 1997	Substantially Equivalent	Medtronic Minimed
K964384	MODEL D-290P ADMINISTRATION SET	Jan 27, 1997	Substantially Equivalent	Patient Solutions, Inc.
K960771	SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM	Dec 10, 1996	Substantially Equivalent	Rymed Technologies, Inc.
K955775	SAFECONNECT VALVE (CATALOG NO. XXXX)	Nov 15, 1996	Substantially Equivalent	Faulding Medical Device Co.
K963112	MMG MULTI LUMON EXTENSION SET	Nov 08, 1996	Substantially Equivalent	Mmg Healthcare, Inc.
K960431	PRESSURE STOPCOCK/MANIFOLD	Oct 29, 1996	Substantially Equivalent	Scientific Device Manufacturer, LLC
K963009	DELTEC SUBCUTANEOUS INFUSION SET	Oct 18, 1996	Substantially Equivalent	Sims Deltec, Inc.
K962893	INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE	Oct 18, 1996	Substantially Equivalent	Baxter Healthcare Corp
K961049	FLEX NEEDLE	Sep 18, 1996	Substantially Equivalent	Lighthouse Medical, Inc.
K961928	BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102	Sep 16, 1996	Substantially Equivalent	Biomedix, Inc.
K963070	VENIPUNCTURE KIT	Sep 13, 1996	Substantially Equivalent	Miller Products and Services
K962802	SAFE MATE I.V. FLUID DELIVERY SETS	Aug 28, 1996	Substantially Equivalent	Biological & Environmental Control Laboratories
K962801	SAFE MATE I.V. EXTENSION SETS	Aug 28, 1996	Substantially Equivalent	Biological & Environmental Control Laboratories
K961794	FLUID ADMINISTRATION SET - CONTRAST MANAGER	Aug 01, 1996	Substantially Equivalent	Merit Medical Systems, Inc.
K955821	I.V. ADMINISTRATION SETS	Jul 10, 1996	Substantially Equivalent	Medical Associates Network, Inc.
K960391	STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771	Jul 03, 1996	Substantially Equivalent	Strato/Infusaid, Inc.
K961495	HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE	Jun 26, 1996	Substantially Equivalent	Baxter Healthcare Corp
K961225	CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET	Jun 21, 1996	Substantially Equivalent	Baxter Healthcare Corp
K954283	ENERGIZED CONTAINER SYSTEM (MODIFICATION)	May 29, 1996	Substantially Equivalent	Abbott Laboratories
K961327	BEC NEEDLELESS INJECTION SITE	May 15, 1996	Substantially Equivalent	Biological & Environmental Control Laboratories
K955585	V2 INJECTION SITE	May 15, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K961474	POLYFIN INFUSION SET MMT-106/MMT-107/MMT-133	May 06, 1996	Substantially Equivalent	Medtronic Minimed
K955410	SNAPDOSE DEVICE	May 06, 1996	Substantially Equivalent	Abbott Laboratories
K954883	FREE FLOW SAFETY DEVICE	Apr 23, 1996	Substantially Equivalent	Migada, Inc.
K960280	IVAC NEEDLE FREE VALVE ADMINISTRATION SETS	Apr 04, 1996	Substantially Equivalent	Y
K960661	MAXCESS NEEDLE FREE CONNECTOR (8200)	Mar 21, 1996	Substantially Equivalent	Solopak Medical Products, Inc.
K953825	ANGIOFLUSH II FLUID MANAGEMENT SYSTEM	Feb 26, 1996	Substantially Equivalent	AngioDynamics, Inc.
K954969	POLYFIN QR SUBCUTANEOUS INFUSION SET	Feb 22, 1996	Substantially Equivalent	Medtronic Minimed
K955732	VENTED SOLUTION SET	Feb 21, 1996	Substantially Equivalent	Distronic Sterile Products, Inc.
K955709	WINGED & SUBCUTANEOUS INFUSION SETS	Feb 21, 1996	Substantially Equivalent	Distronic Sterile Products, Inc.
K952852	NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET	Feb 16, 1996	Substantially Equivalent	Critical Device Corp.
K955783	VLV SA.EF INFUSION PORT EXTENSION SETS	Feb 07, 1996	Substantially Equivalent	Vlv Associates, Inc.
K954823	VENIPUNCTURE KIT	Jan 30, 1996	Substantially Equivalent	Winfield Industries
K953746	ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET	Jan 26, 1996	Substantially Equivalent	Arrow Intl., Inc.
K954983	EXTENSION SET WITH CHECK VALVE	Jan 23, 1996	Substantially Equivalent	Distronic Sterile Products, Inc.
K940832	I.V. ADMINISTRATION SET CONNECTING DEVICE	Jan 23, 1996	Substantially Equivalent	Sierra Medical Devices
K950970	INFUSION SET	Dec 18, 1995	Substantially Equivalent	Surgiplast , Ltd.
K954870	SIMS DELTEC ANTI-SIPHON VALVE	Dec 15, 1995	Substantially Equivalent	Sims Deltec, Inc.
K954841	MODEL D-285N ADMINISTRATION SET	Dec 11, 1995	Substantially Equivalent	Patient Solutions, Inc.
K954813	ICU EXTENSION KIT	Nov 29, 1995	Substantially Equivalent	Icu Medical, Inc.
K954123	LOW PROFILE SAFSITE Y-SITE	Nov 21, 1995	Substantially Equivalent	B.Braun Medical, Inc.
K953791	VLV SA EF INFUSION PORT	Oct 30, 1995	Substantially Equivalent	Vlv Associates, Inc.
K953343	NEEDLELESS INJECTION SITE	Oct 26, 1995	Substantially Equivalent	Medical Associates Network, Inc.
K953584	LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG	Oct 24, 1995	Substantially Equivalent	Abbott Laboratories
K951665	PP-SPF1 / PP-SPF2	Oct 17, 1995	Substantially Equivalent	Patriot Products, Inc.
K953474	IV START KIT	Oct 02, 1995	Substantially Equivalent	Medikmark, Inc.
K953225	IVAC BALL VALCE ADMIN. SETS	Sep 27, 1995	Substantially Equivalent	Y
K933898	HUBER NEEDLE SETS	Sep 27, 1995	Substantially Equivalent	Mediziv Medical Products 1987 , Ltd.
K952160	INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)	Sep 21, 1995	Substantially Equivalent	Medex, Inc.
K952976	PLASTIC BLUNT CANNULA	Sep 15, 1995	Substantially Equivalent	Marquette Medical, Inc.
K952242	TRANSFEER SPIKE II	Sep 15, 1995	Substantially Equivalent	The Medi-Dose Group
K952810	DOSI-FLOW, MODELS 20 & 30	Sep 08, 1995	Substantially Equivalent	Leventon, S.A.
K953231	PPMI-(XXX) AND PPMO-(XXX)	Sep 07, 1995	Substantially Equivalent	Patriot Products, Inc.
K950895	HARMAC EXTENSION INFUSION SET	Sep 01, 1995	Substantially Equivalent	Harmac Medical Products, Inc.
K950153	VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES	Aug 24, 1995	Substantially Equivalent	Imed Corp.
K952760	FIXED FLOW RATE GRAVITY ADMINISTRATION SETS	Aug 18, 1995	Substantially Equivalent	I-Flow Corp.
K952664	SOLUTION ADMINISTRATION SET	Aug 07, 1995	Substantially Equivalent	Distronic Sterile Products, Inc.
K952392	MLI SET	Aug 07, 1995	Substantially Equivalent	Medical Technologies of Georgia
K952074	SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER	Jul 27, 1995	Substantially Equivalent	Baxter Healthcare Corp
K950597	CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE	Jul 26, 1995	Substantially Equivalent	Distronic Sterile Products, Inc.
K951922	ADMINISTRATION SETS WITH BALL FLOAT	Jul 19, 1995	Substantially Equivalent	Imed Corp.
K942988	FILTERED EXTENSION SETS	Jul 14, 1995	Substantially Equivalent	B. Braun of America, Inc.
K942271	LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE	Jul 12, 1995	Substantially Equivalent	Level 1 Technologies, Inc.
K943591	VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM	Jun 28, 1995	Substantially Equivalent	Infusion Technology Intl.
K945298	SMARTFLOW I ADMINISTRATION SET	Jun 14, 1995	Substantially Equivalent	River Medical, Inc.
K952053	E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS	May 31, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K944692	C-SERIES HOMEPUMP	May 02, 1995	Substantially Equivalent	Block Medical, Inc.
K943770	LOW VOLUME MULTIPORT	Apr 10, 1995	Substantially Equivalent	B. Braun of America, Inc.
K943038	STATLOCK-IPIDURAL	Apr 10, 1995	Substantially Equivalent	Venetec, Inc.
K944824	SUREWING	Mar 29, 1995	Substantially Equivalent	Gainor Medical U.S.A., Inc.
K942931	STATLOCK SECUREMENT DEVICES	Mar 28, 1995	Substantially Equivalent	Venetec, Inc.
K944293	SABRATEK SABSIL SETS	Mar 23, 1995	Substantially Equivalent	Sabratek Corp.
K950304	DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER	Mar 14, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K950303	DESERET(R) I.V. LOOP AND DESERET (R) J LOOP	Mar 14, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K950302	E-Z SET(R) AND MINICATH(R) INFUSION SETS	Mar 13, 1995	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K946082	BEECH PRO LOK FIXED	Mar 13, 1995	Substantially Equivalent	Beech Medical Products, Inc.
K933848	PRESPO 7, SELF-SUFFICIENT DRIP DEVICE	Mar 03, 1995	Substantially Equivalent	Bonding Corp.
K942446	I.V. ROLLER GUARD CLAMP	Feb 17, 1995	Substantially Equivalent	Plastic Manufacturing and Marketing Group, Inc.
K944320	VENTED/NON-VENTED GEMINI ADMINISTRATION SET	Feb 14, 1995	Substantially Equivalent	Imed Corp.
K945617	PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS	Feb 13, 1995	Substantially Equivalent	Pharma-Plast Intl. A/S
K943897	NU-SITE	Feb 10, 1995	Substantially Equivalent	Medex, Inc.
K942349	MICROBORE EXTENSION SET	Feb 08, 1995	Substantially Equivalent	Excelsior Medical Corp.
K940657	IV BAG PUMP	Feb 03, 1995	Substantially Equivalent	I-Flow Corp.
K941190	CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET	Jan 31, 1995	Substantially Equivalent	Icu Medical, Inc.
K944619	I.V.I.D. FLUID ADMINISTRATION SET MARKER	Jan 26, 1995	Substantially Equivalent	Advanced Bioresearch Assoc.
K935811	BOLUS DISPENSER	Jan 20, 1995	Substantially Equivalent	I-Flow Corp.
K945070	VERSASAE PLASTIC CANNULA- 11 GAUGE	Jan 13, 1995	Substantially Equivalent	Imed Corp.
K944208	IV ADMINISTRATION SET FPA	Dec 13, 1994	Substantially Equivalent	Medex, Inc.
K941244	SAFELINE SYSTEM TURN LOCK CANNULA	Nov 29, 1994	Substantially Equivalent	Mcgaw, Inc.
K940319	R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE	Nov 10, 1994	Substantially Equivalent	R-Group Intl.
K942046	PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE	Oct 04, 1994	Substantially Equivalent	Pharmacia Deltec, Inc.
K940697	BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK	Aug 30, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K941453	CHECK VALVE SOLUTION SET	Aug 16, 1994	Substantially Equivalent	Douglas Medical Products Corp.
K924010	REDINOV PERFUSION SET	Aug 15, 1994	Substantially Equivalent	Bipress, Inc.
K934095	IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS	Aug 10, 1994	Substantially Equivalent	Y
K934513	PROVIDER PUMP SET W/INFUSION CARTRIDGE	Jul 29, 1994	Substantially Equivalent	Abbott Laboratories
K942181	SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116	Jul 14, 1994	Substantially Equivalent	Medtronic Minimed
K941445	EXTENSION SET WITH ANTI-SIPHON VALVE	Jun 29, 1994	Substantially Equivalent	Pharmacia Deltec, Inc.
K940897	IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET	Jun 22, 1994	Substantially Equivalent	Y
K934119	ENERGIZED DRUG CONTAINER SYSTEM	Jun 09, 1994	Substantially Equivalent	Abbott Laboratories
K925733	ISOFLUX IXL FLOW REGULATOR	May 09, 1994	Substantially Equivalent	Ferguson Medical
K925732	ISOFLUX IXZ FLOW REGULATOR	May 09, 1994	Substantially Equivalent	Ferguson Medical
K925731	ISOFLUX IXP FLOW REGULATOR	May 09, 1994	Substantially Equivalent	Ferguson Medical
K940867	CONTROL-A-FLO(TM) REGULATOR	May 05, 1994	Substantially Equivalent	Baxter Healthcare Corp
K926448	I.V. ADMINISTRATION SET	May 02, 1994	Substantially Equivalent	Gainor Medical Europe, Ltd.
K940054	MEASURED VOLUME SOLUTION ADMINISTRATION SET	Apr 15, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K931173	PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH	Apr 15, 1994	Substantially Equivalent	Imed Corp.
K932165	INTRAVASCULAR ADMINISTRATION SET	Apr 13, 1994	Substantially Equivalent	Mcgaw, Inc.
K940056	WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM	Apr 04, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K940053	INFUSION ADMINISTRATION SET	Mar 28, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K933326	LIFECARE PLUMSET VENTED SECONDARY I.V. SET	Mar 28, 1994	Substantially Equivalent	Abbott Laboratories
K940073	EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30	Mar 23, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K940072	I.V. SET (20 DROPS/ML)	Mar 23, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K940689	WALL IV EXTENSION TUBE	Mar 22, 1994	Substantially Equivalent	Walla Medical Systems, Inc.
K931377	SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT	Mar 07, 1994	Substantially Equivalent	Mcgaw, Inc.
K940296	SAFE CONNECTOR	Feb 22, 1994	Substantially Equivalent	Icu Medical, Inc.
K933390	REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG	Feb 09, 1994	Substantially Equivalent	Pharmacia Deltec, Inc.
K932856	IRRIGATION ACCESS CAP	Jan 26, 1994	Substantially Equivalent	Mcgaw, Inc.
K935601	0.22 MICRON FINAL FILTER WITH EXTENSION TUBE	Jan 21, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K930854	SOLUTION SET WITH .2 MICRON FILTER	Jan 14, 1994	Substantially Equivalent	Douglas Medical Products Corp.
K931550	EZ ADMINISTRATION SET	Jan 10, 1994	Substantially Equivalent	Y
K932637	SUBCUTANEOUS INFUSION SET	Jan 07, 1994	Substantially Equivalent	Douglas Medical Products Corp.
K931659	3 LEAD CONNECTOR	Jan 07, 1994	Substantially Equivalent	Douglas Medical Products Corp.
K933852	PRO-LOK EXTENSION SET	Dec 29, 1993	Substantially Equivalent	Beech Medical Products, Inc.
K933749	BEECH VERSA LOK	Dec 29, 1993	Substantially Equivalent	Beech Medical Products, Inc.
K933732	BEECH PROLOK	Dec 29, 1993	Substantially Equivalent	Beech Medical, Inc.
K931658	IN-LINE BURETTE SET	Dec 21, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K932638	HUBER NEEDLE INFUSION SET	Dec 14, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K932446	INJECTION SITE	Nov 29, 1993	Substantially Equivalent	3M Health Care, Ltd.
K931119	DURHAM; NON CORING WINGED ADMINISTRATION SET	Nov 03, 1993	Substantially Equivalent	Intl. Medical Consultants
K930974	DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK	Nov 03, 1993	Substantially Equivalent	Intl. Medical Consultants
K930927	DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE	Nov 03, 1993	Substantially Equivalent	Intl. Medical Consultants
K925418	ENERGIZED CONTAINER SYSTEM	Nov 03, 1993	Substantially Equivalent	Abbott Laboratories
K912069	AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET	Oct 14, 1993	Substantially Equivalent	3M Avi, Inc.
K930926	DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE	Oct 12, 1993	Substantially Equivalent	Intl. Medical Consultants
K922115	IVAC NEEDLELESS INJECTION VALVE	Oct 12, 1993	Substantially Equivalent	Y
K925645	SELEC-3	Sep 27, 1993	Substantially Equivalent	Biomedix, Inc.
K930751	DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE	Sep 03, 1993	Substantially Equivalent	Intl. Medical Consultants
K930750	DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER	Sep 03, 1993	Substantially Equivalent	Intl. Medical Consultants
K930410	DURHAM; LUER LOCK EXTENSION SET	Sep 03, 1993	Substantially Equivalent	Intl. Medical, Inc.
K930406	DURHAM; MIN BORE LUER LOCK EXTENSION SET	Sep 03, 1993	Substantially Equivalent	Intl. Medical, Inc.
K925362	SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET	Aug 28, 1993	Substantially Equivalent	Baxter Healthcare Corp
K925930	MPC-150 MALE TO MALE LUER ADAPTER	Aug 16, 1993	Substantially Equivalent	Molded Products, Inc.
K925927	MPC-1000 INJECTION CAP/PLUG	Aug 16, 1993	Substantially Equivalent	Molded Products, Inc.
K926119	EXEL HUBER INFUSION SET ROTATING WING	Aug 11, 1993	Substantially Equivalent	Exel Intl.
K925430	LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER	Aug 03, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K925058	BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET	Aug 03, 1993	Substantially Equivalent	C.R. Bard, Inc.
K930855	REPLACEMENT CAP	Jul 30, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K925228	IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL	Jul 30, 1993	Substantially Equivalent	Y
K926184	DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT	Jul 27, 1993	Substantially Equivalent	Douglas Medical Products Corp.
K925219	IVION ADMIN SETS W/FLOW CLIPS	Jul 27, 1993	Substantially Equivalent	Ivion Corp.
K931813	NEEDLESAFE HANDGUARD	Jul 22, 1993	Substantially Equivalent	Adrian Anesthesia Systems, Inc.
K924721	BAXTER SOLUTION ADMINISTRATION SETS	Jul 20, 1993	Substantially Equivalent	Baxter Healthcare Corp
K921322	MORSE ANESTHESIA MANIFOLD	Jul 09, 1993	Substantially Equivalent	Namic
K925126	INTERLINK(TM) INJECTION SITE	Jun 18, 1993	Substantially Equivalent	Baxter Healthcare Corp
K924718	SHROUDED NEEDLE DEVICES	Jun 18, 1993	Substantially Equivalent	Imed Corp.
K923560	ACCU-DROP I.V. EXTENSION SET	Jun 17, 1993	Substantially Equivalent	Lamtic, Inc.
K922637	HORIZON PUMP Y-TYPE BLOOD SET	Jun 04, 1993	Substantially Equivalent	Mcgaw, Inc.
K924207	AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET	May 26, 1993	Substantially Equivalent	3M Health Care, Ltd.
K921899	INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET	Apr 20, 1993	Substantially Equivalent	Baxter Healthcare Corp
K922469	PRO-LOK EXTENSION SET(S)	Mar 15, 1993	Substantially Equivalent	Vlv Associates, Inc.
K923882	IV-TUBE SECURE	Dec 24, 1992	Substantially Equivalent	Ximedix, Inc.
K921594	HAEMOTROL MODEL #HT-SB/6 BURETTE SET	Dec 24, 1992	Substantially Equivalent	Haemotronic, Inc.
K921429	SOLUTION ADMINISTRATION SET	Dec 17, 1992	Substantially Equivalent	Sierra Medical Devices
K904663	AUTO SASH (TM)	Nov 23, 1992	Substantially Equivalent	Block Medical, Inc.
K913982	LIFESHIELD ANESTHESIA SET	Nov 05, 1992	Substantially Equivalent	Abbott Laboratories
K922558	INTERLINK(TM) INJECTION SITE	Oct 19, 1992	Substantially Equivalent	Baxter Healthcare Corp
K920537	SUBCUTANEOUS INFUSION SET	Oct 13, 1992	Substantially Equivalent	Marquette Medical, Inc.
K921674	LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE	Sep 23, 1992	Substantially Equivalent	Strato Medical Corp.
K921576	STRATO LIFEPORT LARGE BORE INFUSION SET	Sep 21, 1992	Substantially Equivalent	Starto Medical Corp.
K915571	CLAVE CONNECTOR	Sep 21, 1992	Substantially Equivalent	Icu Medical, Inc.
K921391	SOLUTION ADMINISTRATION SET	Sep 02, 1992	Substantially Equivalent	Douglas Medical Products Corp.
K921860	MODIFICATION TO IV SPIKE	Jul 30, 1992	Substantially Equivalent	Mcgaw, Inc.
K915678	MERIT ADMINISTRATION SET	Jul 30, 1992	Substantially Equivalent	Merit Medical Systems, Inc.
K921703	CONTINU-FLO(R) SOLUTION SET	Jun 04, 1992	Substantially Equivalent	Baxter Healthcare Corp
K915828	INJECTION SITE WITH LUER LOCK	May 15, 1992	Substantially Equivalent	Baxter Healthcare Corp
K915109	RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET	May 08, 1992	Substantially Equivalent	Ballard Medical Products
K920694	8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET	Mar 23, 1992	Substantially Equivalent	Baxter Healthcare Corp
K915390	3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES	Mar 12, 1992	Substantially Equivalent	Baxter Healthcare Corp
K914924	CHEMO PRIMING PIN(TM)	Mar 06, 1992	Substantially Equivalent	Block Medical, Inc.
K913337	INJECTION CAP	Feb 11, 1992	Substantially Equivalent	Cp Medical
K914113	ANGIOGRAPHIC FLUSH SYSTEM	Jan 22, 1992	Substantially Equivalent	E-Z-Em, Inc.
K914792	PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET	Jan 15, 1992	Substantially Equivalent	Filtertek, Inc.
K905208	MORSE ANESTHESIA	Jan 10, 1992	Substantially Equivalent	North American Instrument Corp.
K914026	ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM	Jan 09, 1992	Substantially Equivalent	E-Z-Em, Inc.
K912856	MEDE-FLO I.V. EXTENSION SET	Dec 17, 1991	Substantially Equivalent	Medevice, Inc.
K914048	NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE	Nov 27, 1991	Substantially Equivalent	Baxter Healthcare Corp
K913333	I.V. PRIMING SET	Oct 23, 1991	Substantially Equivalent	Gainor Medical Europe, Ltd.
K914074	8000 SERIES VOLUMETRIC PUMP SOLUTION SET	Oct 21, 1991	Substantially Equivalent	Baxter Healthcare Corp
K913076	I.V. INSTANT TIMER	Oct 17, 1991	Substantially Equivalent	The Master Medical Corp.
K912861	FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-	Sep 24, 1991	Substantially Equivalent	Biocor, Inc.
K913627	3 PORT ADAPTER	Sep 23, 1991	Substantially Equivalent	Baxter Healthcare Corp
K913311	SAFETY INJECTION PORT, MODIFICATION	Sep 13, 1991	Substantially Equivalent	Riverside Technology, Inc.
K912141	VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE	Sep 11, 1991	Substantially Equivalent	Baxter Healthcare Corp
K911128	MEDIZIV INFUSION SET	Sep 06, 1991	Substantially Equivalent	Medicia Medical Products
K910159	WINGED ADMININ. SET W/NON-CORING NEEDLE	Sep 06, 1991	Substantially Equivalent	Dmd Products
K912860	INTRAVASCULAR ADMINISTRATION SETS	Aug 28, 1991	Substantially Equivalent	Pacific Device, Inc.
K911815	3RD HAND HELPER	Aug 02, 1991	Substantially Equivalent	Aaron Medical Industries
K911443	INSUL-LINE	Jul 26, 1991	Substantially Equivalent	Trademark Corp.
K911868	INTERLINK(TM) BLUNT CANNULA, MODIFICATION	Jun 24, 1991	Substantially Equivalent	Baxter Healthcare Corp
K911753	INTERVASCULAR ADMINSTRATION SET	Jun 24, 1991	Substantially Equivalent	Mcgaw, Inc.
K911931	LUER LOCK INJECTION CAP	Jun 18, 1991	Substantially Equivalent	Dmd Products
K911136	B-D SAFETY-LOK(TM) I.V. NEEDLES	Jun 14, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K905219	4' LOW VOLUME IV EXTENSION SET	Jun 04, 1991	Substantially Equivalent	Marquette Medical, Inc.
K905218	4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP	Jun 04, 1991	Substantially Equivalent	Marquette Medical, Inc.
K905374	IV EXTENSION SETS WITH .22 MICRON FILTER	May 31, 1991	Substantially Equivalent	Marquette Medical, Inc.
K910142	SPARK KIT(R), MODIFICATION	May 14, 1991	Unknown	Lyphomed, Inc.
K910546	PIGGY LOCK NEEDLE HOUSING	Apr 29, 1991	Substantially Equivalent	Icu Medical, Inc.
K910695	AUTO SASH (TM)	Mar 21, 1991	Substantially Equivalent	Block Medical, Inc.
K904886	VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS	Jan 11, 1991	Substantially Equivalent	Florida Infusion Services, Inc.
K902858	AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET	Dec 14, 1990	Substantially Equivalent	3M Avi, Inc.
K904685	EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y)	Nov 21, 1990	Substantially Equivalent	Exel Intl.
K902810	STERILE I.V. START KIT	Nov 13, 1990	Unknown	Orion Life Systems, Inc.
K902109	STATLOCK IV CONNECTOR AND ANCHOR SET	Oct 19, 1990	Substantially Equivalent	Venetec, Inc.
K901089	LOW VOLUME TRIFURCATED IV EXTENSION SET	Oct 04, 1990	Substantially Equivalent	Marquette Medical, Inc.
K901088	LOW VOLUME BIFURCATED IV EXTENSION SET	Oct 04, 1990	Substantially Equivalent	Marquette Medical, Inc.
K900336	V SET	Oct 04, 1990	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K904217	PRO-LOK (TM) EXTENSION SETS	Oct 03, 1990	Substantially Equivalent	Vlv Associates, Inc.
K903809	PROTECTED NEEDLE WITH OR WITHOUT IV SET	Oct 03, 1990	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K904013	SPIVE NEEDLE SYSTEM, MODIFICATION	Oct 01, 1990	Substantially Equivalent	Pascall Medical Corp.
K902330	E-Z FLO + SET	Sep 21, 1990	Substantially Equivalent	Prn Services, Inc.
K903541	SAFETY INJECTION PORT	Sep 14, 1990	Substantially Equivalent	Du-Call Miller Plastics, Inc.
K901949	IV SET	Sep 12, 1990	Substantially Equivalent	Jfv, Inc.
K896896	KAWASUMI SMALL VEIN INFUSION SET	Sep 12, 1990	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K896895	KAWASUMI I.V. ADMINISTRATION SET	Sep 12, 1990	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K896894	KAWASUMI BLOOD ADMINISTRATION SET	Sep 12, 1990	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K896893	KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE	Sep 12, 1990	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K896892	KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET	Sep 12, 1990	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K902166	WINGED INFUSION SET	Aug 17, 1990	Substantially Equivalent	Therex Corp.
K895770	EXEL HUBER INFUSION SET	Jul 19, 1990	Substantially Equivalent	Exel Intl.
K901151	I.V. ADMINISTRATION SET CONNECTING DEVICE	Jul 02, 1990	Substantially Equivalent	Dmd, Div. of Casta Pacific Co.
K902196	MODIFIED STICK-GARD SAFETY NEEDLE	Jun 26, 1990	Substantially Equivalent	Ziehm International, Inc.
K900353	SHIELDED PIGGYBACK IV NEEDLE	Jun 22, 1990	Substantially Equivalent	Pascall Saringia Medical Corp.
K901729	SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET	Jun 18, 1990	Substantially Equivalent	Ryan Medical, Inc.
K901081	PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY	Jun 08, 1990	Substantially Equivalent	Vlv Associates, Inc.
K901046	VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR	Jun 08, 1990	Substantially Equivalent	Vlv Associates, Inc.
K900909	IN-LINE VIAL CONNECTION SITE	May 18, 1990	Substantially Equivalent	Baxter Healthcare Corp
K900651	TS-1800 MEDICATION TRANSFER SPIKE	May 07, 1990	Substantially Equivalent	The Medi-Dose Group
K900188	ADVANCE ADMINISTRATION SETS (VARYING LENGTH)	May 01, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K900187	ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)	May 01, 1990	Substantially Equivalent	Advance Medical Designs, Inc.
K900644	I.V. FREEDOM CLIP	Mar 09, 1990	Substantially Equivalent	Infection Control Products, Inc.
K900427	IV TRIFURCATED EXTENSION SET	Feb 28, 1990	Substantially Equivalent	Marquette Medical, Inc.
K900426	IV BIFURCATED EXTENSION SET	Feb 28, 1990	Substantially Equivalent	Marquette Medical, Inc.
K897065	PORT INFUSION SET (PIS) INFUSION SET (IS)	Feb 16, 1990	Substantially Equivalent	Prn Services, Inc.
K896561	EXTENSION SET	Feb 01, 1990	Substantially Equivalent	Westmark, Sterile Packing Systems, Inc. (Sps)
K896346	GRIPPER PORT-A-CATH NEEDLE WITH STOPCOCK	Jan 18, 1990	Substantially Equivalent	Pharmacia Deltec, Inc.
K896161	AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA.	Jan 11, 1990	Substantially Equivalent	3M Company
K895291	IV DISPESNSING SPIKE	Dec 27, 1989	Substantially Equivalent	The Medi-Dose Group
K895290	CHEMO-SPIKE RECONSTITUTION DEVICE	Dec 27, 1989	Substantially Equivalent	The Medi-Dose Group
K893646	VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY	Dec 06, 1989	Substantially Equivalent	Baxter Healthcare Corp
K896291	INJECTION PORT II --- FOR INTERMITTENT INJECTION	Dec 01, 1989	Substantially Equivalent	The Medi-Dose Group
K895480	BLUNT NEEDLE PORT/I.V. PORT	Dec 01, 1989	Substantially Equivalent	Applied Medical Technologies
K895046	REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE	Oct 25, 1989	Substantially Equivalent	Pharmacia Deltec, Inc.
K895481	SHAMROCK SAFETY WINGED INFUSION SET	Oct 10, 1989	Substantially Equivalent	Ryan Medical, Inc.
K895367	INTRAVENOUS EXTENSION SET	Oct 06, 1989	Substantially Equivalent	Medical Product Specialists
K895109	SECONDARY IV SET WITH PROTECTED NEEDLE	Sep 27, 1989	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K891193	MEDI-TRACE ACCU-NATE DEVICE	Sep 19, 1989	Substantially Equivalent	Graphic Controls Corp.
K893716	VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000	Sep 18, 1989	Substantially Equivalent	Baxter Healthcare Corp
K894787	MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT	Sep 13, 1989	Substantially Equivalent	New York Blood Center, Inc.
K894842	IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM	Sep 12, 1989	Substantially Equivalent	Imed Corp.
K893909	MODIFIED MATERIAL USED IN INFUSION T	Aug 25, 1989	Substantially Equivalent	Quinton, Inc.
K893120	KIT, INTRAVENOUS EXTENSION TUBING	Jul 27, 1989	Substantially Equivalent	Island Medical
K892429	INJECTION PORT FOR---INTERMITTENT INJECTION	Jul 25, 1989	Substantially Equivalent	The Medi-Dose Group
K892440	KENDALL CURITY EXTENSION TUBES	Jul 24, 1989	Substantially Equivalent	The Kendal Co.
K892438	KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES	Jul 24, 1989	Substantially Equivalent	The Kendal Co.
K891164	SAMUELS - MICRO -SCLER CATHETER	Jun 23, 1989	Substantially Equivalent	Polyval, Inc.
K891146	TERUMO SURFLO(R) INJECTION PLUG	Jun 23, 1989	Substantially Equivalent	Terumo Medical Corp.
K891063	SURFLO(R) WINGED INFUSION SET	Jun 23, 1989	Substantially Equivalent	Terumo Medical Corp.
K890489	EXTENSION SET W/FLOW REGULATOR	Jun 08, 1989	Substantially Equivalent	Baxter Healthcare Corp
K891226	VASCULAR ACCESS PORT CONTINUOUS INFUSION SET	May 30, 1989	Substantially Equivalent	Infucare Products, Inc.
K891176	INJECTION SITE PLUG (INTRAVASCULAR ADMINISTRATION)	May 18, 1989	Substantially Equivalent	Multi-Med, Inc.
K885031	LOW ADSORPTION ADMINISTRATION SET	May 05, 1989	Substantially Equivalent	3M Company
K890679	SCALP VEIN SET	May 01, 1989	Substantially Equivalent	Ashley Health Care, Inc.
K890176	EXTENSION SETS WITH AND WITHOUT FILTERS	Apr 26, 1989	Substantially Equivalent	Medical Support Systems
K891072	INTRAVASCULAR ADMINISTRATION SET	Apr 21, 1989	Substantially Equivalent	Multi-Med, Inc.
K884511	SAFE MULTIPORT INJECTOR	Apr 04, 1989	Substantially Equivalent	L & W Ent.
K890340	INTRAVASCULAR ADMINISTRATION SET	Mar 31, 1989	Substantially Equivalent	Multi-Med, Inc.
K884657	LILY I.V. SET	Mar 22, 1989	Substantially Equivalent	Modec Co., Inc.
K884141	MONOPLACE HYPERBARIC EXTENSION SET (L 11055)	Feb 28, 1989	Substantially Equivalent	Abbott Laboratories
K883986	CRIS ADAPTER	Feb 24, 1989	Substantially Equivalent	Y
K885264	WINGED INFUSION SET	Jan 31, 1989	Substantially Equivalent	E-Z-Em, Inc.
K884102	MODIFIED 7 INCH CONTINUOUS INFUSION SETS	Jan 31, 1989	Substantially Equivalent	Quinton, Inc.
K885030	STANDARD ADMINISTRATION SETS	Jan 24, 1989	Substantially Equivalent	3M Company
K883764	INTRAVASCULAR ADMINISTRATION SET	Dec 19, 1988	Substantially Equivalent	Device Labs, Inc.
K884264	HIGH RISK NEEDLE CONNECTOR ASSEMBLY	Nov 14, 1988	Substantially Equivalent	Venture Molded Products, Inc.
K884053	PRN PLUS + INFUSION SET	Oct 31, 1988	Substantially Equivalent	Prn Services, Inc.
K883318	VALLEYLAB I.V. ADMINISTRATION SETS	Oct 21, 1988	Substantially Equivalent	Valleylab, Inc.
K883612	LECTROSPIRAL	Sep 29, 1988	Substantially Equivalent	Vygon Corp.
K883638	SAFESITE INJECTION SITE AND BLUNT CANNULA	Sep 23, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882347	HARMAC EXTENSION INFUSION SET	Aug 30, 1988	Substantially Equivalent	Harmac Medical Specialties, Inc.
K882503	30 IV EXTENSION SET W/TWO MALE LUER LOCKS	Aug 25, 1988	Substantially Equivalent	Churchill Medical Systems, Inc.
K881975	SET, INTRAVASCULAR	Jul 29, 1988	Substantially Equivalent	Primrose Medical, Inc.
K882798	MULTIFLO ADAPTER	Jul 18, 1988	Substantially Equivalent	Deseret Medical, Inc.
K882797	LUER-LOK MULTIFLO ADAPTER	Jul 18, 1988	Substantially Equivalent	Deseret Medical, Inc.
K882302	IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080	Jul 12, 1988	Substantially Equivalent	Y
K882007	EXTENDED LIFE INJECTION SITE	Jun 20, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881321	BLOOD/SOLUTION SET W/PRESSURE PUMP	Jun 16, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881234	VENOVALVE(TM)	Jun 13, 1988	Substantially Equivalent	Abbott Laboratories
K881052	CHECK VALVE	May 26, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881390	NEEDLE SHIELD NEEDLE DISPOSAL UNIT	Apr 29, 1988	Substantially Equivalent	Xenetics Biomedical, Inc.
K880928	MARQUETTE MEDICAL, INC. IV EXTENSION SETS	Apr 29, 1988	Substantially Equivalent	Marquette Medical, Inc.
K874725	SITE SOLUTION ADMINISTRATION SET	Apr 01, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K880482	SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH	Mar 18, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874307	MODEL DMC-75 MINI-CATHETER SET	Jan 29, 1988	Substantially Equivalent	Life-Tech Intl., Inc.
K874581	IVAC(R) DUAL RATE ADAPTER - MODEL 70090	Jan 19, 1988	Substantially Equivalent	Y
K874133	MX710 SERIES VASCULAR ACCESS INFUSION SET	Jan 14, 1988	Substantially Equivalent	Medex, Inc.
K874467	SET, ADMINISTRATION INTRAVASCULAR	Jan 06, 1988	Substantially Equivalent	Kendall Mcgaw Laboratories, Inc.
K872953	DISPOSABLE I.V. ADMINISTRATION SET	Jan 06, 1988	Substantially Equivalent	Mac Lee Medical Products
K874403	A SERIES OF 7 INCH CONTINUOUS INFUSION SETS	Dec 29, 1987	Substantially Equivalent	Quinton, Inc.
K873729	RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET	Dec 29, 1987	Substantially Equivalent	Critikon Company, LLC
K873894	CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE	Nov 05, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K873885	PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET	Nov 03, 1987	Substantially Equivalent	Pharmacia Deltec, Inc.
K873876	PHARMACIA DELTEC BAG SPIKE SET	Oct 23, 1987	Substantially Equivalent	Pharmacia Deltec, Inc.
K873042	MODEL 1330 EXTENSION SET	Oct 23, 1987	Substantially Equivalent	Pharmacia Deltec, Inc.
K871995	MICROS(TM)	Oct 23, 1987	Substantially Equivalent	Controlled Release Technologies, Inc.
K872945	LOOK FLUID DISTRIBUTION SET	Oct 22, 1987	Substantially Equivalent	Look, Inc.
K872124	CHURCHILL ALBUMIN IV ADMINISTRATION SET	Oct 13, 1987	Substantially Equivalent	Churchill Corp.
K872123	CHURCHILL TPN ADMINISTRATION SET	Oct 09, 1987	Substantially Equivalent	Churchill Corp.
K872795	CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE	Sep 04, 1987	Substantially Equivalent	Medex, Inc.
K870995	SCALP VEIN SET	Jul 31, 1987	Substantially Equivalent	Mac Lee Medical Products
K871843	TWO FLUID W/CHECK VALVE	Jul 21, 1987	Substantially Equivalent	Panamedix, Inc.
K870866	THE GRIPPER(TM) PORT-A-CATH NEEDLES	Jun 25, 1987	Substantially Equivalent	Pharmacia, Inc.
K871842	TWO FLUID I.V. SETS	Jun 24, 1987	Substantially Equivalent	Panamedix, Inc.
K871841	THREE FLUID I.V. SETS	Jun 24, 1987	Substantially Equivalent	Panamedix, Inc.
K871732	CHURCHILL-H VENTED IV SET W/METERING CHAMBERS	Jun 15, 1987	Substantially Equivalent	Churchill Corp.
K871086	IV PUMP SET	Jun 15, 1987	Substantially Equivalent	Churchill Corp.
K871753	MASTER MEDICAL DEVICE IS I.V. STAT 2	Jun 05, 1987	Substantially Equivalent	The Master Medical Corp.
K870582	LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE	Apr 23, 1987	Substantially Equivalent	Strato Medical Corp.
K870581	LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET	Apr 23, 1987	Substantially Equivalent	Strato Medical Corp.
K870940	SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.	Mar 17, 1987	Substantially Equivalent	Travenol Laboratories, S.A.
K870913	INJECTION SITE #014456-120	Mar 17, 1987	Substantially Equivalent	Clinical Connections, Inc.
K864296	S.C.T. MULTI PORT, INJECTION SITE	Mar 02, 1987	Substantially Equivalent	Salt Creek Medical Technologies
K870188	NORFOLK MEDICAL BUTTERFLY INFUSION SET	Feb 10, 1987	Substantially Equivalent	Norfolk Medical Products, Inc.
K864453	EMERGENCY & MILITARY INFUSION SYSTEM	Jan 20, 1987	Substantially Equivalent	Migada, Ltd.
K864405	MANAN CONTRAST MEDIA ADMINISTRATION SET	Dec 18, 1986	Substantially Equivalent	Manan Manufacturing Co., Inc.
K864164	CRIS ADAPTED WITH VOLUME LIMITING BAG	Dec 16, 1986	Substantially Equivalent	Y
K863304	PRESELECTED FLOW RATE I.V. SET	Dec 09, 1986	Substantially Equivalent	Migada, Ltd.
K864338	SECONDARY SET LOCK	Nov 19, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K863814	BAG SPIKE EXTENSION SET	Oct 14, 1986	Substantially Equivalent	Med Fusion Systems, Inc.
K862289	KOREAN GREEN CROSS SCALP VEIN SET	Sep 23, 1986	Substantially Equivalent	Sturbridge Medical
K862491	EXEL BUTTERFLY SCALP VEIN SET	Aug 27, 1986	Substantially Equivalent	Exel Intl.
K860952	I.V. SET WITH AND WITHOUT AIR VENT	Aug 27, 1986	Substantially Equivalent	Migada, Ltd.
K862653	LUER LOCK ADAPTER/NUT	Jul 31, 1986	Substantially Equivalent	Mallinckrodt Critical Care
K861182	TIMELINE VENIPUNCTURE SYSTEM	Jun 04, 1986	Substantially Equivalent	Ipax, Inc.
K860609	TIMELINE VENIPUNCTURE SYSTEM	Jun 04, 1986	Substantially Equivalent	Ipax, Inc.
K861275	HIGH FLOW I.V. SET	Jun 02, 1986	Substantially Equivalent	Migada, Ltd.
K860616	VOLUME CONTROL SET WITH EXTENSION	Jun 02, 1986	Substantially Equivalent	Med Fusion Systems, Inc.
K861521	UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)	May 27, 1986	Substantially Equivalent	Jufrey Multimed Corp.
K861520	UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)	May 27, 1986	Substantially Equivalent	Jufrey Multimed Corp.
K861519	UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330F)	May 27, 1986	Substantially Equivalent	Jufrey Multimed Corp.
K861518	UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205F)	May 27, 1986	Substantially Equivalent	Jufrey Multimed Corp.
K861250	MESULIN, INSULIN INFUSION SET	May 23, 1986	Substantially Equivalent	Molnlycke A/S Hospital Products
K861430	CHURCHILL INJECTION SITE	May 12, 1986	Substantially Equivalent	Churchill Corp.
K861439	CHURCHILL FEMALE LUER LOCK CAP	May 06, 1986	Substantially Equivalent	Churchill Corp.
K860157	NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET	Apr 09, 1986	Substantially Equivalent	Quest Medical, Inc.
K860322	CLINISET INFUSION SET	Apr 07, 1986	Substantially Equivalent	Zimmar Consulting , Ltd.
K852616	MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE	Apr 07, 1986	Substantially Equivalent	Medical Hospital Equipment
K860541	SOLUTION ADMINISTRATION SET	Mar 25, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K860605	FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER	Mar 24, 1986	Substantially Equivalent	Migada, Ltd.
K854365	IV SETS WITH NO PHTHALATE PLASTICIZER COMPONENTS	Mar 24, 1986	Substantially Equivalent	Migada, Ltd.
K860272	SOLUTION ADMINISTRATION SETS	Mar 18, 1986	Substantially Equivalent	Travenol Laboratories, S.A.
K854806	RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER	Feb 25, 1986	Substantially Equivalent	Grant Medical Center
K854965	IN LINE VALVE CATALOG NO. 2000A	Feb 21, 1986	Substantially Equivalent	Rao Medical Devices, Inc.
K860242	JMS INFUSION SET	Feb 13, 1986	Substantially Equivalent	Sturbridge Medical
K854804	MULTIPLE I.V. SETS	Feb 12, 1986	Substantially Equivalent	C. B. Dumont Company, Inc.
K860201	PARENTERAL ADMINISTRATION SET	Feb 04, 1986	Substantially Equivalent	Migada, Ltd.
K854754	PATIENTMATE TM	Feb 04, 1986	Substantially Equivalent	Trend Medical, Inc.
K854658	CHURCHILL - HBC VENTED BALL CHECK IV SET	Jan 27, 1986	Substantially Equivalent	Churchill Corp.
K854574	IVAC CONTROLLED RELEASE INFUSION SYSTEM	Jan 23, 1986	Substantially Equivalent	Y
K854628	CHURCHILL-HCM VENTED IV SET	Jan 09, 1986	Substantially Equivalent	Churchill Corp.
K854446	TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET	Jan 09, 1986	Substantially Equivalent	Terumo Medical Corp.
K854636	CHURCHILL-HE VENTED IV SET	Dec 10, 1985	Substantially Equivalent	Churchill Corp.
K854630	CHURCHILL-HS SUSPENDED NON-VENTED IV SET	Dec 10, 1985	Substantially Equivalent	Churchill Corp.
K854627	CHURCHILL-HS SUSPENDED VENTED IV SET	Dec 10, 1985	Substantially Equivalent	Churchill Corp.
K854437	CHURCHILL-H VENTED IV SET	Dec 05, 1985	Substantially Equivalent	Churchill Corp.
K854436	CHURCHILL-H SCALP VEIN SET	Dec 05, 1985	Substantially Equivalent	Churchill Corp.
K854435	CHURCHILL-H NON-VENTED IV SET	Dec 05, 1985	Substantially Equivalent	Churchill Corp.
K854346	MEDIFLEX DISPOSABLE TUBING CLAMP	Nov 18, 1985	Substantially Equivalent	Mediflex Intl.
K852254	I.V. STAT MASTER	Nov 18, 1985	Substantially Equivalent	The Master Medical Corp.
K853019	NITROGLYCERIN INFUSION SET	Nov 12, 1985	Substantially Equivalent	Lyphomed, Inc.
K853287	HUBOUT	Oct 17, 1985	Substantially Equivalent	I M, Inc.
K853527	JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET	Sep 23, 1985	Substantially Equivalent	Jufrey Multimed Corp.
K852606	FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)	Sep 19, 1985	Substantially Equivalent	Infarkem Corp.
K853204	CHURCHILL VENTED IV SET	Sep 05, 1985	Substantially Equivalent	Churchill Corp.
K853385	I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT	Aug 23, 1985	Substantially Equivalent	Migada, Ltd.
K853255	OMNIMED I.V. SOLUTION ADMIN. SET	Aug 23, 1985	Substantially Equivalent	Omni Intl., Inc.
K851516	CHERMEL SCALP VEIN SET	Aug 23, 1985	Substantially Equivalent	Cher Mel Corp.
K853387	ET - EXTENSION SETS	Aug 22, 1985	Substantially Equivalent	Migada, Ltd.
K853327	JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION	Aug 21, 1985	Substantially Equivalent	Jufrey Multimed Corp.
K853086	SECONDARY ADMINISTRATION SET	Aug 19, 1985	Substantially Equivalent	Lyphomed, Inc.
K852881	VENTED SECONDARY IV ADMINISTRATION SET	Aug 16, 1985	Substantially Equivalent	Lyphomed, Inc.
K853184	PIGGYMATE I.V. TUBING LOCK	Aug 13, 1985	Substantially Equivalent	Trend Medical, Inc.
K852989	WINGED INFUSION SETS	Jul 26, 1985	Substantially Equivalent	An-Med Intl.
K852361	INTRAVENOUS INJECTION SET	Jul 16, 1985	Substantially Equivalent	The West Co., Inc.
K852488	CONTROLLED RELEASE INFUSION SYSTEM(CRIS)	Jun 27, 1985	Substantially Equivalent	Y
K852259	IVENT INTRAVENOUS ADMINSTRATION SET	Jun 07, 1985	Substantially Equivalent	Ivent Corp.
K852106	I.V. ADMINISTRATION SET	Jun 07, 1985	Substantially Equivalent	Mediflex Intl.
K852140	NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)	May 30, 1985	Substantially Equivalent	North American Instrument Corp.
K851336	IV/0165 INFUSION SET	May 30, 1985	Substantially Equivalent	Infarkem Corp.
K850769	VIGGO ACCESSORIES FOR I.V. THERAPY	May 29, 1985	Substantially Equivalent	Viggo Products
K851299	CORRECT FLO	May 07, 1985	Substantially Equivalent	Norton Performance Plastics Corp.
K850277	VIGGO I.V. ACCESSORIES-VIGGO EXTENSION TUBES ETC.	Apr 12, 1985	Substantially Equivalent	Viggo Products
K844843	IVAC DRUG ADMINISTRATION DEVICE	Apr 09, 1985	Substantially Equivalent	Y
K850506	CORRECT FLO INTRAVASCULAR ADMINISTRATION SET	Apr 01, 1985	Substantially Equivalent	Biomedical Dynamics, Inc.
K850061	MICRO VOLUME DOUBLE LINE EXTENSION SET	Mar 27, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K850533	ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM	Mar 21, 1985	Substantially Equivalent	Atlantic Optical Systems, Inc.
K850339	SPECIAL PROCEDURES PACK	Mar 12, 1985	Substantially Equivalent	Marwood Medical, Inc.
K850507	CRITIKON I.V. ADMINISTRAION SET	Mar 07, 1985	Substantially Equivalent	Critikon Company, LLC
K850112	OMNIMED IV SOLUTION ADMINISTRATION SET	Feb 22, 1985	Substantially Equivalent	Omni Intl., Inc.
K844917	TURN NEEDLE INTRAVENOUS CANNUL, NUB, W/TUBING INTE	Feb 07, 1985	Substantially Equivalent	Turn Needle Intl., Inc.
K850088	ARTERIAL EXTENSION SET	Feb 02, 1985	Substantially Equivalent	Medical Matrix, Inc.
K844820	FLOW MED SK 140 BURET	Jan 28, 1985	Substantially Equivalent	D.R.O. Medical, Inc.
K844937	IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI	Jan 25, 1985	Substantially Equivalent	Y
K843748	ANTI-ASPIRATION VALVE	Jan 03, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K844255	GENT-L-KARE STERILE I.V. START KIT	Dec 19, 1984	Substantially Equivalent	Geneva Laboratories, Inc.
K843090	UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM	Dec 04, 1984	Substantially Equivalent	Geneva Laboratories, Inc.
K843692	FLU VEN I.V. SET 0153-C PERMA-SET	Oct 31, 1984	Substantially Equivalent	Venusa , Ltd.
K843631	MINISET VEIN INFUSION SETS	Oct 19, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K842984	EXTENSION SET W/INJECTION SITE	Oct 16, 1984	Substantially Equivalent	Med Fusion Systems, Inc.
K842351	STERILE DESIGN-CUSTOM STERILE IV KIT	Oct 15, 1984	Substantially Equivalent	Sterile Design, Inc.
K843463	PROVIDER BAG SPIKE W/12 MICROBORE EXTEN	Oct 11, 1984	Substantially Equivalent	Pancretec, Inc.
K842678	I.V. TRANSFER SPIKE	Oct 09, 1984	Substantially Equivalent	Lyphomed, Inc.
K843185	IVAC C80014 Y SOLUTION ADMIN. SET	Sep 20, 1984	Substantially Equivalent	Y
K843054	DEKA SOLUTION ADMIN. SET DK 302-A	Sep 13, 1984	Substantially Equivalent	Deka Research & Development Corp.
K842858	FLUID ADMINISTRATION LINE W/SPIKE 14-923	Sep 11, 1984	Substantially Equivalent	Norton Performance Plastics Corp.
K843249	T-TYPE IV EXTENSION SET	Sep 07, 1984	Substantially Equivalent	Strato Medical Corp.
K842657	ACCESS. TO INTERAVACULAR ADMIN. SET	Aug 17, 1984	Substantially Equivalent	Tanner Corp.
K842088	FLU MET 2	Aug 17, 1984	Substantially Equivalent	Venusa , Ltd.
K842985	T- EXTENSION SET T-04-C	Aug 07, 1984	Substantially Equivalent	Tico Medical Instruments, Inc.
K841717	INTRAVENOUS INJECTION SET	Jul 23, 1984	Substantially Equivalent	Philadelphia Biologics Center
K841562	HESUNG BLOOD TRANSFUSION SETS	Jul 23, 1984	Substantially Equivalent	Amkor Trading Co.
K842143	BENT WINGED MINI-VOL INFUSION SET	Jul 20, 1984	Substantially Equivalent	Med Fusion Systems, Inc.
K841564	HESUNG SCALP VEIN SET	Jul 17, 1984	Substantially Equivalent	Amkor Trading Co.
K841563	HESUNG'S SOLUTION INFUSION SETS	Jul 17, 1984	Substantially Equivalent	Amkor Trading Co.
K841772	HEPARIN CAP, INJECTION CAP MALE LUER-	Jul 06, 1984	Substantially Equivalent	Linton Biomed Corp.
K841859	SECURA SET	Jul 03, 1984	Substantially Equivalent	Diatek, Inc.
K841882	THREE WAY INFUSION SET	Jun 05, 1984	Substantially Equivalent	Med Fusion Systems, Inc.
K841361	SYRINGE ADDITIVE IV ADMIN. SETS	May 21, 1984	Substantially Equivalent	Quest Medical, Inc.
K841186	INFUSION SET SCALP VEIN	May 21, 1984	Substantially Equivalent	Marbex, Inc.
K841185	PLASTIC, STERILE TUBING CLOSED SET	May 21, 1984	Substantially Equivalent	Marbex, Inc.
K841106	DELTA MULTIPLE NON RETURN CONNECTOR	May 14, 1984	Substantially Equivalent	Tefra Med, Inc.
K840443	RETROGRADE INFUSION SET 3ML & 6ML-	Apr 17, 1984	Substantially Equivalent	Tico Medical Instruments, Inc.
K841027	PROVIDER SITE PREP & CHECK STRIP KIT	Apr 16, 1984	Substantially Equivalent	Pancretec, Inc.
K841028	PROVIDER CAP SET	Apr 05, 1984	Substantially Equivalent	Pancretec, Inc.
K840760	HARVARD ANTI-REFLUX Y-SET	Apr 05, 1984	Substantially Equivalent	C.R. Bard, Inc.
K841025	TOP DISPOSABLE INFUSION SET	Mar 30, 1984	Substantially Equivalent	Top Surgical Manufacturers Co.
K840878	QUIK LOK	Mar 30, 1984	Substantially Equivalent	Abbott Laboratories
K840619	I.V. START KIT	Mar 27, 1984	Substantially Equivalent	Marwood Medical, Inc.
K840410	SOLUTION ADMIN. SET STERILE	Mar 19, 1984	Substantially Equivalent	Loversan
K840409	INFUSION SET-STERILE	Mar 19, 1984	Substantially Equivalent	Loversan
K840273	LOPEZ LOCK	Mar 06, 1984	Substantially Equivalent	Icu Medical, Inc.
K840212	CONCENTRATED PLATELET ADMIN. SET	Mar 06, 1984	Substantially Equivalent	American Mcgaw
K833398	MESULIN INSULIN INFUSION SET	Mar 06, 1984	Substantially Equivalent	Molnlycke A/S Hospital Products
K834254	PBC IV SET VENTED	Feb 27, 1984	Substantially Equivalent	Philadelphia Biologics Center
K834253	PBC IV SET NON-VENTED	Feb 27, 1984	Substantially Equivalent	Philadelphia Biologics Center
K834252	PBC EXTENSION SET	Feb 27, 1984	Substantially Equivalent	Philadelphia Biologics Center
K840081	IV ADMINISTRATION SET	Feb 21, 1984	Substantially Equivalent	Lee Medical Intl., Inc.
K833939	NITROGLYCERIN I.V. ADMINISTRATION SET	Feb 21, 1984	Substantially Equivalent	Critikon Company, LLC
K834289	CONTINU-FLO SOLUTION ADMIN. 2C9102	Jan 30, 1984	Substantially Equivalent	Travenol Laboratories, S.A.
K834130	INTRAVENOUS FILTER SET	Jan 30, 1984	Substantially Equivalent	Tri-Med, Inc.
K834071	LYMPHANGIOGRAPHY SET SPECIAL 30G	Jan 25, 1984	Substantially Equivalent	Hyperion, Inc.
K833949	MICRO INFUSION SET	Jan 11, 1984	Substantially Equivalent	Deltec Systems, Inc.
K832284	SOLUTION ADMIN. SET 2C9096 W/10 PVC	Dec 29, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K833740	VENOSET MULTI-MED PIGGYBACK W/IVEX-2	Dec 27, 1983	Substantially Equivalent	Abbott Laboratories
K833741	VENOSET MULTI MED DUAL RATE PIGGYBACK	Dec 22, 1983	Substantially Equivalent	Abbott Laboratories
K833178	SOLUTION ADMINISTRATION LINE W/SPIKE	Nov 30, 1983	Substantially Equivalent	Intramed, Inc.
K833034	UNIVERSAL VENTED & NON/VOLUME INFUS-	Nov 07, 1983	Substantially Equivalent	Y
K833033	INFUSION SET-52-05-1 20 DROPS-MI VOL	Nov 07, 1983	Substantially Equivalent	Y
K833030	INTRAVASCULAR ADMINISTRATION SET	Nov 03, 1983	Substantially Equivalent	Gish Biomedical, Inc.
K832542	I.V. ADMINISTRATION SET	Oct 31, 1983	Substantially Equivalent	Research Industries Corp.
K832549	SOLUTION ADMIN. LINE W/SPIKE	Oct 27, 1983	Substantially Equivalent	Vascular Specialties, Inc.
K832622	WINGED INFUSION SET	Oct 14, 1983	Substantially Equivalent	Top Surgical Manufacturers Co.
K832434	HBO-1 PASS-THROUGH/EXTENSION TUBE	Sep 20, 1983	Substantially Equivalent	Nauset Labs
K832105	ADMINISTRATIVE IV SET	Sep 12, 1983	Substantially Equivalent	Lee Medical Intl., Inc.
K832104	STERILE DISP. BUTTERFLY INFUSION SET	Sep 12, 1983	Substantially Equivalent	Lee Medical Intl., Inc.
K831445	INFUSION SETS #'S 124 & 142 PERSONAL	Sep 12, 1983	Substantially Equivalent	Pacesetter Systems
K832329	STERILE IV SET 4 SIZES	Aug 24, 1983	Substantially Equivalent	Abco Dealers, Inc.
K832123	VENIPUNCTURE VALVE	Aug 12, 1983	Substantially Equivalent	Abbott Laboratories
K831311	SOLUTION ADMIN. SETS W/FLASHBALL	Jun 08, 1983	Substantially Equivalent	Travenol Laboratories, S.A.
K830182	CUSTOM IV SET	May 09, 1983	Substantially Equivalent	Custom Medical, Inc.
K830453	IV ADMINISTRATION SETS - MVP INFUSION	Apr 30, 1983	Substantially Equivalent	Ziehm International, Inc.
K831088	MINI-VOL I.V. SET	Apr 28, 1983	Substantially Equivalent	Beech Medical, Inc.
K831087	MINI-VOL EXTENSION SET	Apr 28, 1983	Substantially Equivalent	Beech Medical, Inc.
K830755	I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-	Apr 28, 1983	Substantially Equivalent	Medical Parameters, Inc.
K830891	SPECIALTY SET MODEL IV7A01	Apr 14, 1983	Substantially Equivalent	Valleylab, Inc.
K830868	COMBISET OR INFUSION SET	Apr 14, 1983	Substantially Equivalent	Pan-Tek Intl., Inc.
K830194	IDAS INFUSION SET	Mar 29, 1983	Substantially Equivalent	Idas America, Ltd.
K830654	INFUSION PUMP RETROGRADE EXTEN. AS 715	Mar 24, 1983	Substantially Equivalent	Narco Scientific
K830565	SECURA SET SECONDARY ADMIN. SET	Mar 09, 1983	Substantially Equivalent	Diatek, Inc.
K830377	SECURA SET PRIMARY ADMIN. SET	Mar 01, 1983	Substantially Equivalent	Diatek, Inc.
K823845	PORT-LOCK	Mar 01, 1983	Substantially Equivalent	Norfolk Medical Products, Inc.
K830448	SECURA SET VOLUME LIMITING SET	Feb 25, 1983	Substantially Equivalent	Diatek, Inc.
K830258	CENTAURSET 300 & 300 P.E.D	Feb 15, 1983	Substantially Equivalent	Centaur Sciences, Inc.
K830152	MINILOOP I.V. CONNECTORS & ADAPTOR	Feb 09, 1983	Substantially Equivalent	Medex, Inc.
K830178	MINILOOP DISPOS. IV CONNECTORS ADAPT.	Feb 07, 1983	Substantially Equivalent	Medex, Inc.
K823214	DOSIMETRIC RELEASE PROGRAM - ADMIN. SET	Jan 12, 1983	Substantially Equivalent	Cutter Laboratories, Inc.
K823346	ACCUSET ADMINISTRATION SET	Nov 30, 1982	Substantially Equivalent	Imed Corp.
K823347	MACRODOT ADD-I-MED ADMIN. SET	Nov 24, 1982	Substantially Equivalent	Imed Corp.
K823027	ACCUDOT 380 SECONDARY I.V. SET	Nov 22, 1982	Substantially Equivalent	Imed Corp.
K822775	INFUS. SETS-9120-50 CM & 9121-100 CM,EXT	Nov 03, 1982	Substantially Equivalent	Cardiac Pacemakers, Inc.
K822848	PRIMARY & SECONDARY I.V. TUBING SETS	Oct 15, 1982	Substantially Equivalent	David Simmonds Co., Inc.
K822836	MICROFLEX-VENOFLUX	Oct 15, 1982	Substantially Equivalent	Exco, Inc.
K822408	BOSTON INFUSION SETS	Sep 30, 1982	Substantially Equivalent	The Boston Medical Group
K822407	BOSTON SCALP VEIN INFUSION SETS	Sep 30, 1982	Substantially Equivalent	The Boston Medical Group
K822406	BOSTON SOLUTION INFUSION SETS	Sep 30, 1982	Substantially Equivalent	The Boston Medical Group
K822354	DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB	Sep 22, 1982	Substantially Equivalent	Valleylab, Inc.
K822027	I.V. ADMINISTRATION SET	Aug 12, 1982	Substantially Equivalent	Baker & Hostetler
K821995	SOLUTION ADMINISTRATION SET (W/O NEEDLE)	Aug 05, 1982	Substantially Equivalent	Bertex Laboratories, Inc.
K821750	DESERET E-Z SET INFUSION SET	Jul 02, 1982	Substantially Equivalent	Warner-Lambert Co.
K821377	AS 700 SERIES INFUSION PUMP ADMIN.	Jul 02, 1982	Substantially Equivalent	Narco Scientific
K821764	DISPOSABLE INTRAVENOUS INJECTION SYSTEM	Jun 29, 1982	Substantially Equivalent	Medical Systems Research
K821624	LOW VOLUME INFUSTION SET	Jun 22, 1982	Substantially Equivalent	Lifemed of California
K821578	VENOSET DUAL-RATE PIGGYBACK W/IVEX &	Jun 22, 1982	Substantially Equivalent	Abbott Laboratories
K821515	VENTED NITROGLYCERIN I.V. SET	Jun 09, 1982	Substantially Equivalent	Abbott Laboratories
K821032	MODEL SR-1020LF	May 03, 1982	Substantially Equivalent	Stewart-Riess Labs
K820747	MONOJECT SAF-T-LOCK	Apr 15, 1982	Substantially Equivalent	Sherwood Medical Co.
K820788	CLIRANS PRIMING SET	Apr 06, 1982	Substantially Equivalent	Terumo Medical Corp.
K820133	MCGAW FAT EMULSION SET	Apr 06, 1982	Substantially Equivalent	American Mcgaw
K820453	THE INT-STOPPER	Mar 08, 1982	Substantially Equivalent	Burron Medical Products, Inc.
K820278	INTRAVASCULAR ADMINISTRATION SET	Feb 18, 1982	Substantially Equivalent	Y
K820203	FLUID ADMINISTRATIVE SET, AFI	Feb 05, 1982	Substantially Equivalent	Linton Biomed Corp.
K813259	IN-STOPPER (INJECTION CAP	Dec 31, 1981	Substantially Equivalent	Burron Medical Products, Inc.
K813092	ACCUPRO I.V. ADMINISTRATION SET	Dec 31, 1981	Substantially Equivalent	American Mcgaw
K813194	AUTO-SYRINGE SUB-CUTEANEOUS SET	Dec 02, 1981	Substantially Equivalent	Baxter Healthcare Corp
K813083	VENOFIX SCALP VEIN SET	Nov 16, 1981	Substantially Equivalent	Burron Medical Products, Inc.
K812657	INJECTION CAP, LUER LOCK	Oct 23, 1981	Substantially Equivalent	Procedure Products, Inc.
K812688	QI 1150-1T INFUSION T	Oct 02, 1981	Substantially Equivalent	Quinton, Inc.
K811885	30-30-2 700 SYRINGE EXTENSION SET	Aug 25, 1981	Substantially Equivalent	Y
K812231	INTRAVENOUS ADMINISTRATION SET	Aug 20, 1981	Substantially Equivalent	Cordis Corp.
K811914	FLU VEN I.V. SETS	Aug 03, 1981	Substantially Equivalent	Venusa , Ltd.
K811837	I.V. ADMINISTRATION SET	Jul 10, 1981	Substantially Equivalent	Medisystems Corp.
K811078	RADIATION STERILIZED ADMIN. SET	Jul 02, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K811685	I.V. ADMINISTRATION SET	Jun 30, 1981	Substantially Equivalent	Quest Medical, Inc.
K811561	LO-VOL I.V. SETS	Jun 26, 1981	Substantially Equivalent	Sea Medical Products, Inc.
K811463	AUTO-SYRINGE MICRO VOLUME EXTENSION SET	Jun 12, 1981	Substantially Equivalent	Baxter Healthcare Corp
K811107	IV SETS	Jun 12, 1981	Substantially Equivalent	Critikon Company, LLC
K811110	MODELS: 52-01-0, 52-01-1	Jun 11, 1981	Substantially Equivalent	Y
K811006	SOLUTION ADMINISTRATION SET	Jun 02, 1981	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K810239	VENTED PRIMARY PIGGYBACK VENOSET DUAL	May 29, 1981	Substantially Equivalent	Abbott Laboratories
K810317	NITROGLYCERINE IV SET	May 27, 1981	Substantially Equivalent	Abbott Laboratories
K810921	MALE LUER LOCK PLUGS	May 21, 1981	Substantially Equivalent	Procedure Products, Inc.
K810721	PROCESS CHANGE	Apr 23, 1981	Substantially Equivalent	Medlon, Inc.
K802170	SURU BLOOD COLLECTION SET	Apr 06, 1981	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K802169	SURU INFUSION SET TYPE J	Apr 06, 1981	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K810365	HAEMONETICS 170 Y INFUSION SET	Mar 31, 1981	Substantially Equivalent	Haemonetics Corp.
K802329	DISPOSABLE CONSTRAST DELIVERY SPIKE KIT	Oct 03, 1980	Substantially Equivalent	Stanco Medical, Inc.
K801874	MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD	Aug 27, 1980	Substantially Equivalent	Y
K801873	MODEL 86-21-0 260 SECONDARY MEDICATION	Aug 27, 1980	Substantially Equivalent	Y
K801872	MODEL 86-01-1 260 SOLUTION ADMIN. SET	Aug 27, 1980	Substantially Equivalent	Y
K801871	PRIMARY SOLUTION ADMIN. SET-#86-01-0 260	Aug 27, 1980	Substantially Equivalent	Y
K801821	FLOW MED 150	Aug 13, 1980	Substantially Equivalent	D.R.O. Medical, Inc.
K801613	MODEL 72-81-0 UNVENTED SOLUTION ADM. SET	Aug 12, 1980	Substantially Equivalent	Y
K801540	MCGRAW I.V. ADMINISTRATION SET	Aug 12, 1980	Substantially Equivalent	American Hospital Supply Corp.
K800878	SECONDARY I.V. TUBING SETS	Jun 17, 1980	Substantially Equivalent	Harvard Laboratories
K801179	FLOW MED 160	May 30, 1980	Substantially Equivalent	D.R.O. Medical, Inc.
K800711	VOLUMETRIC PUMP CASSETTE W/ATTACHED SET	May 08, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800638	PLASMA PRODUCTS CO. NON-VENTED INTRA/SET	May 08, 1980	Substantially Equivalent	Plasma Products Co.
K800637	PLASMA PRODUCTS CO., INTRA/ADMIN/SET-	May 08, 1980	Substantially Equivalent	Plasma Products Co.
K801004	FLOW MED 160	May 02, 1980	Substantially Equivalent	D.R.O. Medical, Inc.
K800600	B-D STASET, I.V. FLOW CONTROLLER	Apr 16, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K800403	MCGAW/EPIC I.V. ADMIN. SET	Apr 16, 1980	Substantially Equivalent	American Hospital Supply Corp.
K800358	Y-TYPE INFUSION SET (2 LEAD)	Apr 16, 1980	Substantially Equivalent	Haemonetics Corp.
K791496	LOW PLASTICIZER ADMINISTRATION SETS	Apr 08, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800137	PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN	Mar 20, 1980	Substantially Equivalent	Abbott Laboratories
K792228	VENTED I.V. SET	Jan 16, 1980	Substantially Equivalent	Abbott Laboratories
K792560	MASTER I.V. DIAL LOCK	Dec 20, 1979	Substantially Equivalent	The Master Medical Corp.
K792538	CONTINU-FLO ADMIN. SET CODE 2C/200	Dec 20, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K791930	IV EXTENSION SET SL	Oct 26, 1979	Substantially Equivalent	Abbott Laboratories
K791672	ALBUMIN INTRAVENOUS ADMINISTRATION SET	Oct 26, 1979	Substantially Equivalent	Delmed, Inc.
K791529	INFUSION NEEDLE SET	Oct 02, 1979	Substantially Equivalent	I.M.P. Group , Ltd.
K791173	SURFLO INJECTION PLUG	Jul 30, 1979	Substantially Equivalent	Terumo America, Inc.
K790901	I.V. TUBING ORGANIZER	Jun 27, 1979	Substantially Equivalent	Acumed Instruments Corp.
K790582	INTRAVASCULAR ADMINISTRATION SET	May 29, 1979	Substantially Equivalent	Y
K790604	CUSTOM TUBING SETS	May 04, 1979	Substantially Equivalent	Norton Performance Plastics Corp.
K790574	EPIC D215	Apr 30, 1979	Substantially Equivalent	National Patent Development Corp.
K790424	FLU-VEN 01510	Apr 30, 1979	Substantially Equivalent	Venospital, Inc.
K790408	T-CONNECTOR	Apr 30, 1979	Substantially Equivalent	Medex, Inc.
K790077	BIOSTIL # 3884	Apr 30, 1979	Substantially Equivalent	Venospital, Inc.
K790062	IV ADMINISTRATION SET WITH BACKCHECK	Apr 10, 1979	Substantially Equivalent	National Patent Development Corp.
K790108	FILTERSET 0.22, I.V. PUMP	Mar 06, 1979	Substantially Equivalent	Imed Corp.
K782134	FILTER FOR HYPERALIMENTATION SET	Jan 17, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K781813	SOLUTION ADMINISTRATION, TIP PROTECTOR	Jan 17, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K781637	MODEL IV 1500 STANDARD BURETTE	Dec 12, 1978	Substantially Equivalent	Valleylab, Inc.
K781812	SOLUTION ADMINISTRATION, FLEX VALVE	Dec 07, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K781785	I.V. SET WITH IN-LINE FILTER	Dec 07, 1978	Substantially Equivalent	Cutler Laboratories, Inc.
K781744	IV SET WITH GRADUATED CHAMBER	Dec 07, 1978	Substantially Equivalent	National Patent Development Corp.
K781575	DISPOSABLE LYMPHANGIOGRAM SET	Dec 04, 1978	Substantially Equivalent	Instranetics, Inc.
K781190	INFUSION SET, VENOTHIN 21	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781189	FLU VEN 0151	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781188	INFUSION SET, VENOTHIN 25	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781187	INFUSION SET W/ INJECTION SITE, 23D-W	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781186	INFUSION, VENOTHIN 23	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781185	INFUSION SET W/ INJECTION SITE	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781184	INFUSION SET, VENOTHIN 19	Aug 10, 1978	Substantially Equivalent	Venospital, Inc.
K781036	AUTO-SYRINGE INFUSION SET	Aug 10, 1978	Substantially Equivalent	Baxter Healthcare Corp
K780970	BURETTE SET WITH AIR CONTROL LEVER	Jul 27, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780658	STERILE BLOOD ADMINISTRATION SET	Jul 19, 1978	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K780657	STERILE BLOOD COLLECTION SET	Jul 19, 1978	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K780656	STERILE INFUSION SET TYPE J	Jul 19, 1978	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K780655	STERILE INFUSION SET TYPE S	Jul 19, 1978	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K780559	DISPOSABLE INFUSION SET	Jun 06, 1978	Substantially Equivalent	Ks Medical Supply Co.
K780551	I.V. ADMINISTRATION SET WITH MINI-SPIKE	Apr 19, 1978	Substantially Equivalent	National Patent Development Corp.
K780481	I.V. LEVER CLAMP	Apr 10, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780130	BURETTE INTRAVENOUS ADMIN. SETS.	Feb 21, 1978	Substantially Equivalent	Y
K771983	SCALP VEIN SET	Jan 05, 1978	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K772008	SCALP VEIN SETS	Jan 03, 1978	Substantially Equivalent	Suru Chemicals & Pharmaceuticals, Ltd.
K772036	IN-LINE BURETTE SET	Nov 16, 1977	Substantially Equivalent	Abbott Laboratories
K771593	I.V. PUMP SET FOR FAT EMULSION	Sep 12, 1977	Substantially Equivalent	Abbott Laboratories
K771271	SCALP VEIN SET	Sep 12, 1977	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K771270	BLOOD ADMINISTRATION TYPE R	Sep 12, 1977	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K771268	INFUSION SET TYPE J	Sep 12, 1977	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K771267	INFUSION SET TYPE S	Sep 12, 1977	Substantially Equivalent	Berman, Pcp & Consultants, Inc.
K771453	FLUID HANDLING DEVICE W/INPUT TUBING	Aug 22, 1977	Substantially Equivalent	Imed Corp.
K771362	FLU VEN 0150	Aug 22, 1977	Substantially Equivalent	Venospital, Inc.
K771339	MALE LUER LOCK PLUG	Aug 02, 1977	Substantially Equivalent	American Viggo
K771204	SURFLO WINGED INFUSION SET	Jul 14, 1977	Substantially Equivalent	Terumo America, Inc.
K770743	SOLUSET FOR IV FAT EMULSION	Jun 24, 1977	Substantially Equivalent	Abbott Laboratories
K770863	FLU VEN 0160	Jun 14, 1977	Substantially Equivalent	Venospital, Inc.
K770763	BURETTE SET, 2C0132	Jun 08, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K770744	IV SET THAT REVERTS TO KVO RATE	May 26, 1977	Substantially Equivalent	Abbott Laboratories
K770589	FILTER, INTRAVENOUS W/AUTO AIR VENT	May 23, 1977	Substantially Equivalent	Jelco Laboratories
K770518	PIGGYBACK VENOSET W/0.22 FILTER	Apr 29, 1977	Substantially Equivalent	Abbott Laboratories
K770171	ERIKA I.V. ADMINISTRATION SET	Mar 30, 1977	Substantially Equivalent	Erika, Inc.
K770051	VENOSET FOR I.V. FAT EMULSION	Feb 08, 1977	Substantially Equivalent	Abbott Laboratories
K761327	IV SETS 2000 SERIES (HS-200,2L0,220)	Jan 31, 1977	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K760111	FILTER, I.V., WITH FLASH BULB (#4701)	Jul 16, 1976	Substantially Equivalent	Jelco Laboratories
K760110	FILTER, I.V. (#4700)	Jul 16, 1976	Substantially Equivalent	Jelco Laboratories
K760103	CAP, INJECTION (#4600)	Jul 16, 1976	Substantially Equivalent	Jelco Laboratories