Product Code: FOZ FDA class 2 21 CFR 880.5200

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

General Hospital

The Short-Term Intravascular Therapeutic Catheter (less than 30 days) is a flexible tube inserted into a blood vessel for periods under 30 days to deliver fluids, medications, nutrition, or to perform hemodynamic monitoring. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FOZ, regulated under 21 CFR 880.5200 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

497

FEI Numbers

212

Registration Numbers

213

Unique Applicants

242

Years Active

Basic Information

Product Code: FOZ
Device Class: FDA class 2
Regulation Number: 880.5200
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 497 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251155	BD Cathena Safety IV Catheter	Jul 11, 2025	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K251654	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter	Jun 27, 2025	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K250682	BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	Jun 03, 2025	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K243105	Ruby Intravascular Catheter	May 16, 2025	Substantially Equivalent	Venocare, Inc.
K250292	OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)	May 02, 2025	Substantially Equivalent	SkyDance Vascular, Inc.
K244059	HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)	Mar 27, 2025	Substantially Equivalent	Access Vascular, Inc.
K243599	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00818)	Mar 14, 2025	Substantially Equivalent	Arrow International, LLC (A Subsidiary of Teleflex, Inc.)
K242281	Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)	Dec 20, 2024	Substantially Equivalent	Arrow International, LLC (A Subsidiary of Teleflex, Inc.)
K241115	SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter	Nov 27, 2024	Substantially Equivalent	Spectrum Vascular
K240359	PowerGlide Pro Midline Catheter	Jul 29, 2024	Substantially Equivalent	Becton, Dickinson and Company (Bard Access Systems, Inc.)
K241845	Introcan Safety® 2 IV Catheter	Jul 26, 2024	Substantially Equivalent	B. Braun Medical Inc.
K233106	AccuCath Ace Intravascular Catheter	Apr 19, 2024	Substantially Equivalent	Bard Access Systems, Inc. (C.R. Bard, Inc.)
K232234	Nouvo Safety Set	Mar 15, 2024	Substantially Equivalent	Poly Medicure Limited
K233529	BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector	Dec 01, 2023	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K231239	Nexiva Closed IV Catheter System with NearPort IV Access	Sep 22, 2023	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K231401	Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva	Sep 21, 2023	Substantially Equivalent	Poly Medicure Limited
K223788	The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter	Sep 15, 2023	Substantially Equivalent	MedSource International LLC
K231626	OSPREY Closed IV Catheter System (OspreyV2)	Aug 31, 2023	Substantially Equivalent	SkyDance Vascular, Inc.
K221827	Mais Central Venous Catheter	Jun 23, 2023	Substantially Equivalent	Saudi Mais Co. for Medical Products
K230616	Polyguard and Polyshield Safety IV Catheters	May 05, 2023	Substantially Equivalent	Poly Medicure Limited
K223018	OSPREY PERIPHERAL IV Catheter System	Apr 14, 2023	Substantially Equivalent	SkyDance Vascular, Inc.
K223648	Cook® Spectrum® 2 MRC Central Venous Catheter	Feb 03, 2023	Substantially Equivalent	Cook Advanced Technologies
K220772	HydroMID 4F Single Lumen Midline Catheter	Dec 07, 2022	Substantially Equivalent	Access Vascular, Inc.
K210929	MagiCath II	Sep 13, 2022	Substantially Equivalent	Woo Young Medical Co., Ltd.
K212370	Leaderflex Mini and Leaderflex Nano	Aug 29, 2022	Substantially Equivalent	Vygon USA
K220756	Introcan Safety 2 IV Catheter	Jun 23, 2022	Substantially Equivalent	B.Braun Medical Inc.
K220626	Introcan Safety IV Catheter	May 14, 2022	Substantially Equivalent	B.Braun Medical Inc.
K220584	BD Cathena Safety IV Catheter	Mar 31, 2022	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K210037	Pluski Safe 1 Safety IV Catheter	Mar 25, 2022	Substantially Equivalent	Mediplus (India) Limited
K213664	B. Braun Introcan Safety 2 IV Catheter	Feb 11, 2022	Substantially Equivalent	B. Braun Medical Inc.
K213085	Introcan Safety 3 Closed IV Catheter	Oct 25, 2021	Substantially Equivalent	B.Braun Medical Inc.
K202060	Disposable IV catheter	Jul 23, 2021	Substantially Equivalent	Shinva Ande Healthcare Apparatus Co., Ltd.
K200891	BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System	Jun 02, 2021	Substantially Equivalent	Becton, Dickinson and Company
K203069	HydroMID	Feb 08, 2021	Substantially Equivalent	Access Vascular Inc.
K201075	BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter	Dec 18, 2020	Substantially Equivalent	Becton, Dickinson and Company
K193158	ACENT Central Venous Catheter	Nov 24, 2020	Substantially Equivalent	Global Medikit Limited
K201717	BD Cathena Safety IV Catheter	Sep 22, 2020	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K200373	Deltaven Fast Flash Closed I.V. Catheter Systems	Aug 26, 2020	Substantially Equivalent	Delta Med Spa
K193278	MedSource CathMED IV Catheter	Aug 07, 2020	Substantially Equivalent	MedSource Labs
K192230	MF SAFECATH	Apr 23, 2020	Substantially Equivalent	MediFirst Co., Ltd.
K200266	BD Centro Vena Acute Central Line (7 French Dual Lumen)	Apr 07, 2020	Substantially Equivalent	Bard Access Systems, Inc. (Bard has joined BD)
K192676	Introcan Safety 2 IV Catheter 18-24 gauge	Apr 01, 2020	Substantially Equivalent	B. Braun Medical Inc.
K200263	Health Line CT Midline Catheter	Mar 12, 2020	Substantially Equivalent	Health Line International Corporation
K192493	BD Cathena (TM) Safety IV Catheter	Jan 24, 2020	Substantially Equivalent	Becton, Dickinson Infusion Therapy Systems, Inc.
K192533	Health Line CT CVC	Dec 10, 2019	Substantially Equivalent	Health Line International Corporation
K190855	BD Acute Central Line	Nov 01, 2019	Substantially Equivalent	Bard Access Systems, Inc. (Bard has joined BD)
K190001	Supercath 5	Sep 20, 2019	Substantially Equivalent	TOGO MEDIKIT Co., Ltd.
K191232	AccuCath Ace Intravascular Catheter	Sep 18, 2019	Substantially Equivalent	C.R. Bard, Inc
K182252	Cook Unimpregnated Central Venous Catheter	May 17, 2019	Substantially Equivalent	Cook Incorporated
K183399	BD Nexiva Closed IV Catheter System	Mar 20, 2019	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K182870	Introcan Safety 3 Closed IV Catheter	Mar 07, 2019	Substantially Equivalent	B. Braun Medical Inc.
K182538	Merit RadialFlo Arterial Catheter	Jan 16, 2019	Substantially Equivalent	Merit Medical Singapore Pte. Ltd.
K172496	SUPERCATH 5 (26G)	Mar 23, 2018	Substantially Equivalent	TOGO Medikit Co., Ltd.
K171530	Deltaven XiV Max, Deltaven XiV Max FF	Dec 21, 2017	Substantially Equivalent	Delta Med SpA
K173354	BD Nexiva Diffusics Closed IV Catheter Systems	Dec 15, 2017	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K172506	BD Cathena Safety IV Catheter	Sep 17, 2017	Substantially Equivalent	Becton, Dickinson and Company
K172204	BD Intima II PLUS Closed IV Catheter System	Aug 17, 2017	Substantially Equivalent	Becton, Dickinson and Company
K163358	Introcan Safety 3 Closed IV Catheter	Apr 28, 2017	Substantially Equivalent	B.BRAUN MELSUNGEN AG
K170336	BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector	Mar 10, 2017	Substantially Equivalent	Becton, Dickinson and Company
K161681	Nipro SafeTouch IV Catheter	Mar 08, 2017	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K170283	BD Nexiva Diffusics Closed IV Catheter System	Feb 28, 2017	Substantially Equivalent	Becton, Dickinson and Company
K163513	Arrow Endurance Extended Dwell Peripheral Catheter System	Feb 24, 2017	Substantially Equivalent	Arrow International, Inc. (subsidiary of Teleflex Inc.)
K162894	AccuCath Intravascular Catheter	Nov 15, 2016	Substantially Equivalent	C.R.BARD, INC.
K161779	MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter	Nov 03, 2016	Substantially Equivalent	MedSource International, LLC
K162377	PowerGlide Pro Midline Catheter	Sep 22, 2016	Substantially Equivalent	C.R. BARD, INC.
K161866	BioFlo Midline Catheter	Sep 08, 2016	Substantially Equivalent	NAVILYST MEDICAL, INC.
K161777	BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems	Aug 29, 2016	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.
K160592	SUPERCATH 6	Aug 12, 2016	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K160235	ViaValve Safety I.V. Catheter	Jun 30, 2016	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K153280	PowerGlide Pro Midline Catheter	Jun 02, 2016	Substantially Equivalent	C.R. BARD, INC.
K160374	20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System	Mar 11, 2016	Substantially Equivalent	TANGENT MEDICAL TECHNOLOGIES, INC.
K153298	AccuCath Intravascular Catheter	Dec 10, 2015	Substantially Equivalent	C.R. Bard, Inc.
K152272	Arrow Endurance Extended Dwell Peripheral Catheter System	Nov 23, 2015	Substantially Equivalent	ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
K151698	BD Angiocath IV Catheter, BD Insyte IV Catheter	Jul 27, 2015	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K150611	MedSource ClearSafe Safety IV Catheter	Jul 15, 2015	Substantially Equivalent	MedSource International
K151513	Arrow Endurance Extended Dwell Peripheral Catheter System	Jul 08, 2015	Substantially Equivalent	Arrow Internation, Inc. (subsidiary of Teleflex Inc.)
K142797	I.V. Catheter	Jun 18, 2015	Substantially Equivalent	Jiangxi Sanxin Medtec Co., Ltd
K150109	Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology	Jun 05, 2015	Substantially Equivalent	Arrow International ( a subsidiary of Teleflex, Inc.)
K150407	BioFlo Midline Catheter	May 15, 2015	Substantially Equivalent	NAVILYST MEDICAL, INC.
K143610	BD INTIMA II CLOSED IV CATHETER	Apr 09, 2015	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems Inc.
K142136	ACCUCATH MIDLINE CATHETER SYSTEM	Jan 08, 2015	Substantially Equivalent	VASCULAR PATHWAYS, INC.
K140270	NEXUS MIDLINE CT CATHETER	Aug 20, 2014	Substantially Equivalent	HEALTH LINE INTERNATIONAL CORPORATION
K141026	LEADERFLEX	Jul 30, 2014	Substantially Equivalent	VYGON
K140504	ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM	Jul 17, 2014	Substantially Equivalent	VASCULAR PATHWAYS, INC.
K133280	TERUMO SURFLO I.V. CATHETER	Jun 12, 2014	Substantially Equivalent	TERUMO (PHILIPPINES) CORPORATION
K141138	SURFLASH SAFETY I.V. CATHETER	May 30, 2014	Substantially Equivalent	KOFU FACTORY OF TERUMO CORP.
K140419	SUPERCATH5	May 12, 2014	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K140136	NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE	Feb 14, 2014	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K131555	MEDSOURCE IV SAFETY CATHETER	Jan 31, 2014	Substantially Equivalent	MEDSOURCE INTERNATIONAL, LLC.
K133856	POWERGLIDE MIDLINE CATHETER	Jan 16, 2014	Substantially Equivalent	C.R. BARD, INC.
K132153	SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER	Dec 05, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K130518	MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER	Apr 30, 2013	Substantially Equivalent	LUTHER NEEDLESAFE PRODUCTS, INC.
K121488	JMS SAFE WING CATH (SWC)	Mar 05, 2013	Substantially Equivalent	JMS NORTH AMERICA CORPORATION
K123734	BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM	Jan 17, 2013	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
K121007	NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1	Dec 28, 2012	Substantially Equivalent	DELTA MED SRL
K123267	SURFFLASH(R) PLUS SAFETY I.V. CATHETER	Nov 02, 2012	Substantially Equivalent	KOFU FACTORY OF TERUMO CORP.
K122544	TERUMO SURFLASH SAFETY I.V. CATHETER	Sep 05, 2012	Substantially Equivalent	TERUMO Corporation
K120839	NOVACATH SECURE IV CATHETER SYSTEM-18G	Jul 20, 2012	Substantially Equivalent	TANGENT MEDICAL TECHNOLOGIES, INC.
K111939	M/29TM - PRESSURE INJECTABLE	Jul 11, 2012	Substantially Equivalent	FLEXICATH LTD.
K121073	POWERGLIDE MIDLINE CATHETER	Jun 01, 2012	Substantially Equivalent	C.R. BARD, INC.
K113622	ORION II CT CVC	May 18, 2012	Substantially Equivalent	HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
K113565	MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN	May 18, 2012	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K112290	SUPERCATH Z3V	Apr 16, 2012	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K113700	VIAVALVE SAFETY IV CATHETER	Mar 14, 2012	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K113429	SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER	Mar 12, 2012	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K120337	I-PORT ADVANCE INJECTION PORT	Feb 16, 2012	Substantially Equivalent	UNOMEDICAL A/S
K112542	YOMURA SAFETY I.V. CATHETER	Feb 08, 2012	Substantially Equivalent	YOMURA TECHNOLOGIES INC.
K110794	AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS	Dec 21, 2011	Substantially Equivalent	AMECO MEDICAL INDUSTRIES
K111366	BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM	Sep 30, 2011	Substantially Equivalent	BECTON DICKINSON AND COMPANY (BD)
K112347	RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE	Sep 22, 2011	Substantially Equivalent	VASCULAR PATHWAYS, INC.
K111236	INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1	Aug 30, 2011	Substantially Equivalent	B. BRAUN MELSUNGEN AG
K110443	BD INSYTE AUTOGUARD BC	Jul 19, 2011	Substantially Equivalent	BECTON DICKINSON & CO.
K102520	BD NEXIVA CLOSED IV CATHETER SYSTEM	Jan 06, 2011	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K100775	BD INTIMA II CLOSED IV CATHETER	Jun 03, 2010	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K100974	SPECTRUM TURBO-JECT PICC SET	May 06, 2010	Substantially Equivalent	COOK INCORPORATED
K100282	TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER	Feb 26, 2010	Substantially Equivalent	TERUMO CORP.
K093546	SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX	Dec 17, 2009	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K091709	MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC	Oct 13, 2009	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K092629	SNM FIRMGRIP	Sep 25, 2009	Substantially Equivalent	FLEXICATH LTD.
K083429	I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT	Aug 07, 2009	Substantially Equivalent	WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD.
K090973	TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)	May 01, 2009	Substantially Equivalent	TERUMO CORP.
K082997	TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER	Apr 15, 2009	Substantially Equivalent	TERUMO MEDICAL CORP.
K081953	SUPERCATH 5	Mar 12, 2009	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K090502	NOVA SAFE SCALP VEIN BLOOD COLLECTION SET	Mar 10, 2009	Substantially Equivalent	U.S. SAFETY SYRINGES CO., INC.
K090122	NUOVOGUARD	Feb 05, 2009	Substantially Equivalent	U.S. SAFETY SYRINGES CO., INC.
K083454	NUOVOCATH	Dec 04, 2008	Substantially Equivalent	U.S. SAFETY SYRINGES CO., INC.
K081420	VANISHPOINT I.V. CATHETER	Nov 07, 2008	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K080793	FIRMGRIP	Oct 16, 2008	Substantially Equivalent	FLEXICATH LTD.
K082362	SURSHIELD SAFETY I.V. CATHETER	Sep 17, 2008	Substantially Equivalent	TERUMO MEDICAL CORP.
K081113	COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS	Jul 30, 2008	Substantially Equivalent	COOK, INC.
K081690	SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER	Jul 14, 2008	Substantially Equivalent	COOK, INC.
K073471	VANTAGECATH INTRAVASCULAR CATHETER	Apr 30, 2008	Substantially Equivalent	ADVANTAGE MEDICAL DEVICE
K073520	ANGIOTECH CVC	Apr 11, 2008	Substantially Equivalent	ANGIOTECH PHARMACEUTICALS, INC.
K073241	VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM	Feb 08, 2008	Substantially Equivalent	VASCULAR PATHWAYS
K070705	MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039	Nov 30, 2007	Substantially Equivalent	VYGON CORP.
K072419	ADVANTIV SAFETY I.V. CATHETER	Nov 09, 2007	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K071382	SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,	Oct 16, 2007	Substantially Equivalent	SHIN CHANG MEDICAL CO., LTD.
K071538	ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER	Aug 30, 2007	Substantially Equivalent	ARROW INTERNATIONAL, INC.
K070020	COMCASET-P SAFETY IV CATHETER	Aug 16, 2007	Substantially Equivalent	PITANGO MEDICAL LTD
K070451	ABLE CENTRAL VENOUS CATHETER	Jul 31, 2007	Substantially Equivalent	FOSHAN NANHAI BAI HE MEDICAL TECHNOLOGY CO., LTD
K063469	MEDICAN ALPHA	Dec 01, 2006	Substantially Equivalent	EASTERN MEDIKIT LTD.
K061250	MULTICATH EXPERT	Sep 29, 2006	Substantially Equivalent	VYGON CORP.
K062108	COMCASET SAFETY IV CATHETER	Aug 08, 2006	Substantially Equivalent	PITANGO MEDICAL LTD
K060341	SHERLOCK TIP LOCATION SYSTEM (TLS)	Apr 14, 2006	Substantially Equivalent	C.R. BARD, INC.
K052564	VYGON LEADER-FLEX	Apr 05, 2006	Substantially Equivalent	VYGON CORP.
K052881	VYGON LATEX FREE BIONECTOR	Mar 02, 2006	Substantially Equivalent	VYGON CORP.
K060174	SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM	Feb 17, 2006	Substantially Equivalent	COOK, INC.
K042504	CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER	Jan 19, 2006	Substantially Equivalent	MYCO MEDICAL SUPPLIES, INC.
K053120	STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES	Dec 09, 2005	Substantially Equivalent	EXCELSIOR MEDICAL CORP.
K051355	VANISHPOINT I.V. CATHETER	Sep 23, 2005	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K052389	I-PORT	Sep 09, 2005	Substantially Equivalent	PATTON MEDICAL DEVICES
K050114	SUPERCATH Z3V	Jun 09, 2005	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K043446	EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER	Feb 04, 2005	Substantially Equivalent	EMMEBI SRL
K042862	BD ONECATH	Dec 03, 2004	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K033843	SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING	Aug 12, 2004	Substantially Equivalent	COOK, INC.
K041345	PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES	Jul 22, 2004	Substantially Equivalent	MEDIX, INC.
K040427	FIBREX CATHETER PATENCY DEVICE	May 03, 2004	Substantially Equivalent	MEDICAL DEVICE TECHNOLOGIES, INC.
K032292	BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX	Mar 22, 2004	Substantially Equivalent	BIOTEQUE CORP.
K032843	NEXIVA CLOSED IV CATHETER SYSTEM	Feb 27, 2004	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K032274	COOK FIVE LUMEN CENTRAL VENOUS CATHETER	Feb 26, 2004	Substantially Equivalent	COOK, INC.
K033500	BD CAREFLOW CENTRAL VENOUS CATHETER	Jan 29, 2004	Substantially Equivalent	BECTON DICKINSON & CO.
K033853	MODIFICATION TO V-CATH POLY PICC	Jan 14, 2004	Substantially Equivalent	HDC CORP.
K033250	EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR	Dec 30, 2003	Substantially Equivalent	EDWARDS LIFESCIENCES, LLC.
K032417	HEPARIN LOCK FLUSH SYRINGE	Dec 23, 2003	Substantially Equivalent	AM2 PAT INC.
K032777	MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE	Nov 14, 2003	Substantially Equivalent	NIPRO MEDICAL CORP.
K032962	AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE	Oct 29, 2003	Substantially Equivalent	ARROW INTL., INC.
K030479	JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET	Aug 18, 2003	Substantially Equivalent	JMS NORTH AMERICA CORP.
K024007	SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J	Jul 14, 2003	Substantially Equivalent	SUNDER BIOMEDICAL TECH. CO., LTD.
K021557	SPECTRUM SILICONE CATHETER	May 30, 2003	Substantially Equivalent	COOK, INC.
K023253	PEDIATRIC CENTRAL VENOUS CATHETER KIT	May 06, 2003	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K030571	ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER	Mar 28, 2003	Substantially Equivalent	ETHICON ENDO-SURGERY, INC.
K021130	SPECATH CENTRAL VENOUS CATHETER KITS	Jan 07, 2003	Substantially Equivalent	SPECIAL MEDICAL CO. LTD.
K022756	NIPRO BIO-FLEX CATHETER	Oct 18, 2002	Substantially Equivalent	NIPRO MEDICAL CORP.
K022099	SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S	Sep 20, 2002	Substantially Equivalent	HDC CORP.
K020785	INTROCAN SAFETY IV CATHETER	Aug 28, 2002	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K013182	TRIPLE LUMEN CENTRAL VENOUS CATHETER	Jul 01, 2002	Substantially Equivalent	COOK, INC.
K021139	TRULINE REINFORCED VALVED INFUSION CATHETER	Apr 17, 2002	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K002142	SALINE IV FLUSH SYRINGE	Jan 28, 2002	Substantially Equivalent	EMT-RX
K011967	BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE	Jan 23, 2002	Substantially Equivalent	BD
K013556	MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE	Dec 31, 2001	Substantially Equivalent	TYCO HEALTHCARE
K013800	INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE	Dec 21, 2001	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K013287	NIPRO SAFELET CATH	Dec 03, 2001	Substantially Equivalent	NIPRO MEDICAL CORP.
K013073	INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS	Nov 08, 2001	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K011937	TRULINE INFUSION CATHETERS	Aug 28, 2001	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K012128	PROTECTIV ACUVANCE IV CATHETER SYSTEM	Aug 01, 2001	Substantially Equivalent	ETHICON ENDO-SURGERY, INC.
K011982	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE	Jul 17, 2001	Substantially Equivalent	BD
K011860	KEYST0NE MEDICAL PICC CATHETER	Jun 27, 2001	Substantially Equivalent	KEYSTONE MEDICAL
K011297	NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET	Jun 20, 2001	Substantially Equivalent	NIPRO MEDICAL CORP.
K010410	JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G	Jun 20, 2001	Substantially Equivalent	JMS CO., LTD.
K010406	JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G	Jun 20, 2001	Substantially Equivalent	JMS CO., LTD.
K003187	VACUCATH I.V. CATHETER INTRODUCTER	May 21, 2001	Substantially Equivalent	AUTO/CATH VASCULAR ACCESS, INC.
K003553	0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE	Mar 21, 2001	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K010021	MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S	Feb 23, 2001	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K010034	DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-	Jan 24, 2001	Substantially Equivalent	COOK, INC.
K003245	HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML	Dec 04, 2000	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K002786	BIOSENSORS CENTRAL VENOUS CATHETER KITS	Nov 17, 2000	Substantially Equivalent	SUNSCOPE INTL., INC.
K001795	THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD	Oct 19, 2000	Substantially Equivalent	AVITRO LLC.
K000632	0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE	Oct 19, 2000	Substantially Equivalent	AVITRO LLC.
K000997	ZORTRAN DETECTOR	Sep 07, 2000	Substantially Equivalent	LUCENT MEDICAL SYSTEMS
K001616	MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE	Jul 27, 2000	Substantially Equivalent	ABBOTT LABORATORIES
K002033	BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS	Jul 26, 2000	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K992532	VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING	Jun 13, 2000	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K993518	MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL	Jun 12, 2000	Substantially Equivalent	MEDEFIL, INC.
K000665	TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER	May 02, 2000	Substantially Equivalent	TFX MEDICAL, INC.
K992732	STERILE WATER & STERILE 0.9% SODIUM CHLORIDE	Apr 20, 2000	Substantially Equivalent	DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
K000235	INSYTE CATHETER, INSYTE AUTOGUARD CATHETER	Apr 05, 2000	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K000087	MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR	Mar 17, 2000	Substantially Equivalent	THE KENDAL CO.
K993691	ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	Mar 08, 2000	Substantially Equivalent	ARROW INTL., INC.
K982558	BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE	Mar 08, 2000	Substantially Equivalent	BD/PREEFIL
K993515	MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L	Feb 25, 2000	Substantially Equivalent	MEDEFIL, INC.
K990390	HEPARIN IV FLUSH SYRINGE, 10 U/ML \	Dec 10, 1999	Substantially Equivalent	ROCAP DIV. OF SABRATEK CORP.
K990308	ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML	Dec 10, 1999	Substantially Equivalent	ROCAP DIV. OF SABRATEK CORP.
K984590	0.9% SODIUM CHLORIDE FLUSH SYRINGE	Oct 07, 1999	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K992198	URETHANE PICC LINE MODEL UPICS-	Aug 27, 1999	Substantially Equivalent	COOK, INC.
K990236	MODIFICATION OF JELCO,JELCO-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT	Aug 20, 1999	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
K991406	TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER	Jun 16, 1999	Substantially Equivalent	TERUMO MEDICAL CORP.
K984614	NORMAL SALINE FLUSH SYRINGE	May 27, 1999	Substantially Equivalent	ROCAP DIV. OF SABRATEK CORP.
K984189	ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER	May 05, 1999	Substantially Equivalent	MAXXIM MEDICAL
K984059	ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER	Apr 09, 1999	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K984055	CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS	Jan 29, 1999	Substantially Equivalent	SIMS DELTEC, INC.
K982805	INTROCAN SAFETY IV CATHETER	Jan 14, 1999	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K970736	BRAUN PREFILLED SYRINGE	Dec 16, 1998	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K983916	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)	Nov 23, 1998	Substantially Equivalent	HDC CORP.
K983409	V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1	Oct 16, 1998	Substantially Equivalent	HDC CORP.
K980566	VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER	Sep 14, 1998	Substantially Equivalent	BOSTON SCIENTIFIC CORP.
K981905	STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291	Aug 18, 1998	Substantially Equivalent	ACU-PAK
K974015	ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL	May 18, 1998	Substantially Equivalent	DAVIS & GECK, INC.
K973561	MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M	May 11, 1998	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K981382	PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS	May 01, 1998	Substantially Equivalent	CATHETER INNOVATIONS, INC.
K981368	PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS	May 01, 1998	Substantially Equivalent	CATHETER INNOVATIONS, INC.
K980493	I.V. CATHETER SYSTEM	Apr 28, 1998	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K974764	INTROSYTE CATHETER	Feb 26, 1998	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K974543	L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER	Feb 10, 1998	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K971339	INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS	Dec 24, 1997	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K971991	GESCO PER-Q-CATH MIDLINE CATHETERS	Nov 07, 1997	Substantially Equivalent	BARD ACCESS SYSTEMS, INC.
K971990	GESCO PER-Q-CATH PICC CATHETERS	Nov 07, 1997	Substantially Equivalent	BARD ACCESS SYSTEMS, INC.
K970864	ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS	Oct 17, 1997	Substantially Equivalent	ARROW INTL., INC.
K972264	FIRST MIDCATH CATHETER	Sep 15, 1997	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K972263	FIRST PICC CATHETER WITH DUAL LUMENS	Sep 15, 1997	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K972262	FIRST PICC CATHETER	Sep 15, 1997	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K972254	FIRST MIDCATH CATHETER	Sep 12, 1997	Substantially Equivalent	BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
K963196	VYGON UMBILICAL CATHETHER INSERTION TRAY	Sep 09, 1997	Substantially Equivalent	VYGON CORP.
K962577	ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER	Aug 21, 1997	Substantially Equivalent	ARROW INTL., INC.
K970669	AEROQUIP SAFESTART IV CATHETER	Aug 01, 1997	Substantially Equivalent	AEROQUIP MEDICAL PRODUCTS
K970644	AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM	Jul 31, 1997	Substantially Equivalent	AEROQUIP MEDICAL PRODUCTS
K960764	SAFE-CATH	Apr 24, 1997	Substantially Equivalent	SCIENTIFIC DEVICE MANUFACTURER LLC.
K964966	V-CATH	Mar 05, 1997	Substantially Equivalent	HDC CORP.
K961552	CVP POLYURETHANE CATHETER	Feb 10, 1997	Substantially Equivalent	ABBOTT LABORATORIES
K964050	FIRST MIDCATH CATHETER	Jan 06, 1997	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K964049	FIRST MIDCATH CATHETER WITH DUAL LUMENS	Jan 06, 1997	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K964048	FIRST MIDCATH CATHETER KIT	Jan 06, 1997	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K962226	PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM	Dec 23, 1996	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K953252	DISPOSABLE SCALP VEIN INFUSION SET	Nov 26, 1996	Substantially Equivalent	MYCO MEDICAL SUPPLIES, INC.
K963867	NEO-CARE CATHETERIZATION TRAY	Nov 06, 1996	Substantially Equivalent	KLEIN-BAKER MEDICAL, INC.
K962938	EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)	Oct 25, 1996	Substantially Equivalent	EXCELSIOR MEDICAL CORP.
K953811	MEDCOMP P-CATH	Jul 25, 1996	Substantially Equivalent	MEDCOMP
K953805	0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE	Jun 28, 1996	Substantially Equivalent	ABBOTT LABORATORIES
K954112	VYGON LIFEVAC MID-LINE TRAY	May 09, 1996	Substantially Equivalent	VYGON CORP.
K951620	MIDMARK MIDLINE CATHETER	Apr 04, 1996	Substantially Equivalent	MENLO CARE, INC.
K960051	NIPRO SAFELET CATH	Mar 28, 1996	Substantially Equivalent	NISSHO CORP.
K954428	SOLOPICC 24 (60CM) 20GA CATHETER	Mar 28, 1996	Substantially Equivalent	DOUGLAS MEDICAL PRODUCTS CORP.
K955839	MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER	Mar 25, 1996	Substantially Equivalent	BAXTER EDWARDS
K960013	MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM	Feb 13, 1996	Substantially Equivalent	MDC RESEARCH LTD.
K950118	ABRM CATHETER	Feb 08, 1996	Substantially Equivalent	COOK, INC.
K954887	STERILE WATER O.9% STERILE SALINE	Jan 24, 1996	Substantially Equivalent	LOCKETT MEDICAL CORP.
K953335	MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER	Jan 23, 1996	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K955053	NIPRO SCALP VEIN SET (DISPOSABL PSV SET)	Jan 04, 1996	Substantially Equivalent	NISSHO CORP.
K953120	VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE	Dec 13, 1995	Substantially Equivalent	VITAL SIGNS, INC.
K952645	VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE	Dec 13, 1995	Substantially Equivalent	VITAL SIGNS, INC.
K946170	COMFORT-Q SUBCUTANEOUS INJECTION SETS	Nov 03, 1995	Substantially Equivalent	B. BRAUN OF AMERICA, INC.
K952058	STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE	Sep 21, 1995	Substantially Equivalent	TRINITY LABORATORIES, INC.
K932947	WALLACE Y-CAN	Sep 01, 1995	Substantially Equivalent	SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
K932946	WALLACE IV CANNULA	Sep 01, 1995	Substantially Equivalent	SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
K952861	ANGIOCATH & INSYTE AUTOGUARD CATHETERS	Jul 31, 1995	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K952757	ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER	Jul 31, 1995	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K952256	PICC LINE KIT	Jul 31, 1995	Substantially Equivalent	MEDI-FLEX HOSPITAL PRODUCTS, INC.
K941678	BIONECTOR	Jun 26, 1995	Substantially Equivalent	VYGON CORP.
K950284	SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR	May 23, 1995	Substantially Equivalent	SIMS DELTEC, INC.
K945053	LF CT HIG PRESSURE CATHETERS	May 19, 1995	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K950301	ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS	Apr 18, 1995	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K944302	THE FLEX-SET SUBCUTANEOUS INFUSION SET	Apr 10, 1995	Substantially Equivalent	CATHCO, INC.
K945521	CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY	Apr 06, 1995	Substantially Equivalent	MENLO CARE, INC.
K944410	CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER	Apr 05, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K944368	CATCO SILICONE UMBILICAL VESSEL CATHETER	Apr 05, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K944367	CATCO POLYURETHANE UMBILICAL VESSEL CATHETER	Apr 05, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K944336	CATCO UMBILICAL VESSEL CATHETER	Apr 05, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K944504	CATCO FIRST PICC	Mar 31, 1995	Substantially Equivalent	CATCO MEDICAL, INC.
K950737	LANDMARK MIDLINE CATHETER	Mar 29, 1995	Substantially Equivalent	MENLO CARE, INC.
K944968	LANDMARK MIDLINE CATHETER	Mar 29, 1995	Substantially Equivalent	MENLO CARE, INC.
K943349	MAHURKAR DUAL LUMEN CATHETER	Mar 22, 1995	Unknown	QUINTON, INC.
K944660	ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY	Mar 13, 1995	Substantially Equivalent	NEOSTAR MEDICAL TECHNOLOGIES, INC.
K944511	ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)	Mar 13, 1995	Substantially Equivalent	NEOSTAR MEDICAL TECHNOLOGIES, INC.
K942045	INSYTE INTRODUCER CATHETER	Jan 09, 1995	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K933467	PRN ADAPTER	Dec 12, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K940634	MICRO THERAPEUTICS INFUSION CATHETER	Oct 14, 1994	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K935090	CUFF-CATH	Oct 14, 1994	Substantially Equivalent	OHMEDA MEDICAL
K941417	VITAFLON PLUS/VASCULON	Oct 06, 1994	Substantially Equivalent	HOGAN & HARTSON
K943023	CVD BULLETT PERIPHERAL INFUSION CATHETER	Sep 30, 1994	Substantially Equivalent	CARDIOVASCULAR DYNAMICS, INC.
K932789	ONE-SITE IV CONNECTOR	Jul 28, 1994	Substantially Equivalent	CARE MEDICAL DEVICES, INC.
K940775	INJECTION CAP	Jun 15, 1994	Substantially Equivalent	MEDRON, INC.
K940441	DIAL MEDICAL SUPPLY FISTULA NEEDLE SET	Jun 10, 1994	Substantially Equivalent	DIAL MEDICAL OF FLORIDA, INC.
K940385	NAVIGATOR-MP CATHETER LOCATION INSTRUMENT	Jun 02, 1994	Substantially Equivalent	NAVION BIOMEDICAL CORP.
K930048	SAFE-PICC CATHETER	May 12, 1994	Substantially Equivalent	MENLO CARE, INC.
K931073	CATH-FINDER	May 05, 1994	Substantially Equivalent	PHARMACIA DELTEC, INC.
K926544	PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH	Mar 21, 1994	Substantially Equivalent	PHARMACIA DELTEC, INC.
K931668	PICC INSERTION TRAY	Mar 07, 1994	Unknown	CLINIPAD CORP.
K931729	I.V. START KIT	Feb 22, 1994	Unknown	CARAPACE, INC.
K932071	I.V. START KIT	Feb 17, 1994	Unknown	CLINIPAD CORP.
K931027	BULLETT PERIPHERAL INFUSION CATHETER	Feb 04, 1994	Substantially Equivalent	CARDIO-DYNAMICS, INC.
K926405	.9% NORMAL SALINE TUBE/STERILE WATER TUBE	Feb 03, 1994	Substantially Equivalent	GAM-MED PACKAGING CORP.
K933050	CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH	Dec 14, 1993	Substantially Equivalent	CRITIKON COMPANY,LLC
K923702	INTIMA POINT GUARD INTRAVASCULAR CATHETER	Sep 22, 1993	Substantially Equivalent	BECTON DICKINSON VASCULAR ACCESS, INC.
K926097	CYBILNATE(R) UMBILICAL CATHETER	Aug 31, 1993	Substantially Equivalent	CYEX MEDICAL TECHNOLOGIES, INC.
K923323	INTERMITTENT INJECTION SITE	Jul 13, 1993	Substantially Equivalent	KAWASUMI LABORATORIES CO., LTD.
K924968	L-CATH PEEL-AWAY CATHETER SYSTEM	May 21, 1993	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K914378	PERIPHERAL INTERVENOUS CATHETER	May 20, 1993	Unknown	MEDICAL PROFILES, INC.
K920638	BIO-MATE PIC CATHETER	Mar 26, 1993	Unknown	MEDEVICE, INC.
K921955	QUIK FLOW	Jan 29, 1993	Substantially Equivalent	CALIFORNIA MEDICAL EQUIPMENT, INC.
K915824	HOLE PUNCH	Jan 29, 1993	Substantially Equivalent	AMERICAN BIOMATERIALS CORP.
K914528	SAFEDWEL(R) CENTRAL VENOUS CATHETER	Oct 13, 1992	Unknown	BECTON DICKINSON VASCULAR ACCESS, INC.
K921270	SAFE-DWELL PLUS CENTRAL VENOUS CATHETER	Sep 28, 1992	Unknown	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K920828	SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT	Aug 14, 1992	Unknown	MENLO CARE, INC.
K914180	DESERET(R) FLOW RESTRICTION VALVE	May 08, 1992	Unknown	BECTON DICKINSON VASCULAR ACCESS, INC.
K920635	E-Z SET/MINICATH INFUSION SETS	Apr 06, 1992	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K920133	VERSACATH SELECTALUMEN INNER CATHETER	Mar 26, 1992	Substantially Equivalent	MENLO CARE, INC.
K920128	VERSACATH MAINLINE CENTRAL VENOUS CATHETER	Mar 26, 1992	Substantially Equivalent	MENLO CARE, INC.
K920028	LANDMARK MIDLINE CATHETER	Mar 26, 1992	Substantially Equivalent	MENLO CARE, INC.
K915065	I.V.IRRIGATION POLE	Feb 11, 1992	Substantially Equivalent	AMERICAN MEDICAL MFG., INC.
K912358	LANDMARK ADD-A-LUMEN CATHETER KIT	Jan 02, 1992	Unknown	MENLO CARE, INC.
K912165	LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM	Dec 11, 1991	Unknown	MENLO CARE, INC.
K911251	FLEX-IV	Oct 28, 1991	Substantially Equivalent	MEDWAY
K912158	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	Oct 23, 1991	Unknown	MEDICAL DEVICE INSPECTION CO., INC.
K912563	ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE	Oct 02, 1991	Substantially Equivalent	MBO LABORATORIES, INC.
K905415	BRAIDED HIGH PRESSURE CATHETER CONNECTOR	Aug 12, 1991	Substantially Equivalent	THE R GROUP
K910566	VERSACATH(TM) MULTILUMEN SYSTEM	Jun 03, 1991	Unknown	MENLO CARE, INC.
K910565	VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY	Jun 03, 1991	Unknown	MENLO CARE, INC.
K910564	VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY	May 06, 1991	Substantially Equivalent	MENLO CARE, INC.
K910572	INJECTION CAPS	Apr 29, 1991	Substantially Equivalent	AKCESS MEDICAL PRODUCTS, INC.
K910799	LANDMARK VENOUS ACCESS DEVICE	Mar 21, 1991	Substantially Equivalent	MENLO CARE, INC.
K904558	DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL	Feb 11, 1991	Unknown	DAVOL, INC.
K905463	GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION	Jan 22, 1991	Unknown	ANGIOSYSTEMS, INC.
K905009	DIGITCARE I.V. START KIT	Dec 18, 1990	Unknown	DIGITCARE CORP.
K904648	SAFE SYTE I.V. CATHETER PLACEMENT UNIT	Dec 14, 1990	Substantially Equivalent	DESERET MEDICAL, INC.
K903347	SODIUM CHLORIDE SOLUTION	Dec 13, 1990	Substantially Equivalent	SUPERIOR HEALTHCARE GROUP, INC.
K904150	CATH-FINDER(TM) CATHETER TRACKING SYSTEM	Nov 19, 1990	Substantially Equivalent	PHARMACIA DELTEC, INC.
K903545	CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS	Nov 13, 1990	Unknown	J.J. SKINNER, INC.
K904121	VIALON OBTURATOR	Nov 08, 1990	Substantially Equivalent	DESERET MEDICAL, INC.
K896813	MODIFIED INTRAVENOUS CATHETER	Oct 19, 1990	Substantially Equivalent	SAFEGUARD NEEDLE CO.
K904122	INSYTE-A ARTERIAL CATHETERIZATION UNIT	Oct 04, 1990	Substantially Equivalent	DESERET MEDICAL, INC.
K903732	KENDALL SAFETRAK(TM) HIGH FLOW CATHETER	Oct 03, 1990	Unknown	KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
K901701	CENTRAL VENOUS ACCESS CATHETER	Sep 19, 1990	Substantially Equivalent	CARDIOPULMONICS, INC.
K902527	SPLIT-SECOND INTRODUCER	Sep 12, 1990	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K895597	VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER	Sep 12, 1990	Substantially Equivalent	VAS-CATH, INC.
K895812	SHARGHP INTRAVENOUS CATHETER	Sep 07, 1990	Substantially Equivalent	SHARGH PHARMACEUTICAL CO., INC.
K901263	NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM	Aug 22, 1990	Substantially Equivalent	NAVION BIOMEDICAL CORP.
K900056	CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE	Aug 15, 1990	Substantially Equivalent	ABBOTT LABORATORIES
K901640	MULTICATH PLACEMENT KIT	Aug 10, 1990	Substantially Equivalent	VYGON CORP.
K902135	PERCUTANEOUS INTRODUCER KIT	Aug 01, 1990	Unknown	DEVICE LABS, INC.
K900263	ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER	Jul 24, 1990	Unknown	ARROW INTL., INC.
K895942	GESCO DUAL LUMEN PER-Q-CATH-DL	Jul 02, 1990	Substantially Equivalent	GESCO INTL., INC.
K900116	DESERET OPTIMA INTRAVASCULAR CATHETER	Jun 18, 1990	Substantially Equivalent	DESERET MEDICAL, INC.
K895734	DESERET INTRAVASCULAR CATHETER	Apr 09, 1990	Substantially Equivalent	DESERET MEDICAL, INC.
K895768	EXEL SAFELET CATHETER	Feb 16, 1990	Substantially Equivalent	EXEL INTL.
K896774	STREAMLINE VASCULAR ACCESS DEVICE	Dec 27, 1989	Substantially Equivalent	MENLO CARE, INC.
K894611	CATHETER CARE KITS	Dec 15, 1989	Unknown	L H M ENT., INC.
K895191	ANTI-THROMBOGENIC COATING FOR CATHETERS	Nov 24, 1989	Substantially Equivalent	BURRON MEDICAL, INC.
K893546	OPTICALLY CLEAR RADIOPAQUE CATHETER	Nov 01, 1989	Substantially Equivalent	CRITIKON COMPANY,LLC
K894371	NIPRO SAFELET CATH	Oct 25, 1989	Substantially Equivalent	PHARMA-PLAST USA, INC.
K893965	PROLONG INTRAVASCULAR CATHETER	Sep 08, 1989	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K884577	PROCEDURE READY TRAYS	Aug 01, 1989	Unknown	PROFESSIONAL MEDICAL SERVICES
K893003	TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE	Jul 14, 1989	Unknown	UNITED MEDICAL SYSTEMS, INC.
K891087	TERUMO SURFLO(R) I.V. CATHETER	Jun 23, 1989	Substantially Equivalent	TERUMO MEDICAL CORP.
K884325	SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE	Apr 25, 1989	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K890751	ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT	Apr 21, 1989	Substantially Equivalent	MEDICAL SAFETY PRODUCTS, INC.
K890435	VITAACCESS CATHETER INTRODUCER KIT	Mar 29, 1989	Unknown	VITAPHORE CORP.
K884806	LUMED EXPANDO-CATH, ACTIV	Feb 08, 1989	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K884701	CATH-FINDER SYSTEM	Feb 01, 1989	Substantially Equivalent	PHARMACIA DELTEC, INC.
K883980	LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)	Dec 05, 1988	Substantially Equivalent	MENLO CARE, INC.
K883866	NEOSOFT UMBILICAL VESSEL CATHETER	Nov 21, 1988	Substantially Equivalent	MENLO CARE, INC.
K884259	MODIFIED LANDMARK VENOUS ACCESS DEVICE	Nov 01, 1988	Substantially Equivalent	MENLO CARE, INC.
K883415	VASCULON 2 INTRAVENOUS CANNULA	Oct 04, 1988	Substantially Equivalent	OHMEDA MEDICAL
K881767	VIGGO INSUFLON	Aug 24, 1988	Substantially Equivalent	OHMEDA MEDICAL
K881976	CATHETER, INTRAVASCULAR	Aug 04, 1988	Substantially Equivalent	PRIMROSE MEDICAL, INC.
K882242	LANDMARK(TM) VENOUS ACCESS DEVICE	Jun 20, 1988	Substantially Equivalent	MENLO CARE, INC.
K881215	CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH	Jun 13, 1988	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K881236	TORAY ANTHRON P-U CATHETERS	May 11, 1988	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K881666	HR(TM) INTRAVASCULAR CATHETER	May 06, 1988	Substantially Equivalent	ICU MEDICAL, INC.
K880260	SAFECATH	Apr 19, 1988	Substantially Equivalent	PHASE MEDICAL SYSTEMS, INC.
K872998	VITAACCESS (TM) CATHETER INTRODUCER SYSTEM	Mar 24, 1988	Substantially Equivalent	VITAPHORE CORP.
K875082	O.P.C. INTRAVASCULAR CATHETER	Mar 08, 1988	Substantially Equivalent	TAUT, INC.
K875177	J&J SCALP VEIN INFUSION SETS	Jan 14, 1988	Substantially Equivalent	CRITIKON COMPANY,LLC
K874582	DESERET SPLITTABLE CATHETER	Dec 29, 1987	Substantially Equivalent	DESERET MEDICAL, INC.
K873050	VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF	Oct 20, 1987	Substantially Equivalent	C.R. BARD, INC.
K872585	CHURCHILL-CATH	Oct 15, 1987	Substantially Equivalent	CHURCHILL CORP.
K871546	SAFESIDE(TM) LUMED	Jun 17, 1987	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K870403	CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE	May 01, 1987	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K864949	INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER	Feb 25, 1987	Substantially Equivalent	QUINTON, INC.
K862153	ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE	Dec 11, 1986	Substantially Equivalent	ARROW INTL., INC.
K864038	SUPERCATH I.V. CATHETER	Dec 04, 1986	Substantially Equivalent	TOGO MEDIKIT CO., LTD.
K861725	INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT	Dec 04, 1986	Substantially Equivalent	PARKE-DAVIS CO.
K862130	COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.	Aug 14, 1986	Substantially Equivalent	MENLO CARE, INC.
K862480	BT CATH (INTRAVASCULAR CATHETER)	Jul 31, 1986	Substantially Equivalent	BARON TECHNOLOGIES, INC.
K861479	CAVAFIX, CENTRAL VENOUS CATHETER KIT	Jul 01, 1986	Unknown	BURRON MEDICAL PRODUCTS, INC.
K861117	ANTHRON CATHETERS & SETS	Jun 18, 1986	Substantially Equivalent	TORAY INDUSTRIES (AMERICA), INC.
K861510	MULTILUMEN VIAPIC CENTRAL LINE CATHETER	Jun 09, 1986	Substantially Equivalent	WARNER-LAMBERT CO.
K860474	STREAM LINE* I.V. CATHETER PLACEMENT UNIT	May 06, 1986	Substantially Equivalent	MENLO CARE, INC.
K853988	FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI	May 01, 1986	Substantially Equivalent	FORAN INDUSTRIES, INC.
K861015	ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS	Apr 22, 1986	Substantially Equivalent	ACME UNITED CORP.
K854308	POLYCATH-H CATHETER	Apr 07, 1986	Substantially Equivalent	ABBOTT LABORATORIES
K860256	BRAWN AND GROSHONG CATHETERS	Mar 28, 1986	Substantially Equivalent	CATHETER TECHNOLOGY CORP.
K860290	VIAPIC CENTRAL LINE CATHETER	Mar 18, 1986	Substantially Equivalent	PARKE-DAVIS CO.
K854566	TERUMO SURFLO ETFE I.V. CATHETER	Jan 23, 1986	Substantially Equivalent	TERUMO MEDICAL CORP.
K853348	L-CATH EXPANDO CATH	Jan 09, 1986	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K853701	JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL	Oct 17, 1985	Substantially Equivalent	CRITIKON COMPANY,LLC
K851142	TELET-LEX MEDICAL IV CATHETER PLACEMENT	Jul 05, 1985	Substantially Equivalent	Teleflex Medical, Inc.
K851981	NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC.	Jun 18, 1985	Substantially Equivalent	SUPERIOR PLASTIC PRODUCTS CORP.
K851327	DESERET ARTERIAL CATHETER	Jun 14, 1985	Substantially Equivalent	PARKE-DAVIS CO.
K852078	SPECTRUM(TENTATIVE)	Jun 07, 1985	Substantially Equivalent	PARKE-DAVIS CO.
K844193	QUINTON INJECTION SEALING CAP	May 17, 1985	Substantially Equivalent	QUINTON, INC.
K850887	DRESSING CHANGE KIT	May 01, 1985	Substantially Equivalent	CREATIVE CARE SYSTEMS, INC.
K851101	BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET	Apr 12, 1985	Substantially Equivalent	BIONOMY, INC.
K850276	VIGGO NEOFLON INFUSION CANNULA	Apr 12, 1985	Substantially Equivalent	VIGGO PRODUCTS
K850460	VIGGO SECALON T CATHETER	Apr 11, 1985	Substantially Equivalent	VIGGO PRODUCTS
K850349	VIGGO ARTERIAL CANNULA	Apr 09, 1985	Substantially Equivalent	VIGGO PRODUCTS
K850278	VASCULON I.V. CANNULAE	Apr 09, 1985	Substantially Equivalent	VIGGO PRODUCTS
K850398	NU-CATH EMERGENCY KIT	Mar 27, 1985	Substantially Equivalent	INTL. MEDICAL DEVICES LTD.
K842577	CATH-TECH POLYURETHANE UMBILICAL VESS	Mar 13, 1985	Substantially Equivalent	CATHETER TECHNOLOGY CORP.
K842133	EYRTHROCATH DOUBLE-LUMEN CENTRAL VENOUS	Feb 19, 1985	Substantially Equivalent	CARDIOSEARCH, INC.
K850369	QUINTON WHITE SEALING CAP	Feb 15, 1985	Substantially Equivalent	QUINTON, INC.
K841880	ERYTHROCATH UMBILICAL CATHETER	Jan 14, 1985	Substantially Equivalent	CARDIOSEARCH, INC.
K843033	DESERET INTRAVASCULAR CATHETER	Dec 03, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K844219	DESERET DENTRAL LINE CATHETER	Nov 28, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K844113	DESERET SUBCLAVIAN JUGULAR CATHETER SET	Nov 28, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K840815	LUER LOCKING ADAPTER(MATERIAL CHANGE)	Nov 08, 1984	Substantially Equivalent	QUINTON, INC.
K840116	DESERET INFANT CENTRAL VENOUS CATHE-	Mar 22, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K840862	DESERET CENTRAL VENOUS CATHETER	Mar 19, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K840355	DESERET MULTILUMEN SUBCLAVIAN JUGULAR	Mar 19, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K840183	DESERET MULTILUMEN SUBCLAVIAN JUGULAR	Mar 19, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K834227	DESERET SUBCLAVIAN JUGULAR CATH. SET	Mar 19, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K834255	PBC SCALP VEIN SET	Mar 12, 1984	Substantially Equivalent	PHILADELPHIA BIOLOGICS CENTER
K834073	CENTRAL VEIN CATHERIZATION TRAY CC-20	Feb 28, 1984	Substantially Equivalent	PACKAGING TECHNOLOGIES, INC.
K834393	DESERET NEONATAL CATHETER SET	Feb 13, 1984	Substantially Equivalent	PARKE-DAVIS CO.
K834480	INJECTION CAP	Feb 04, 1984	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K833079	CENTRACATH #130,135 & 137-HEMOCATH #	Dec 29, 1983	Substantially Equivalent	EXCO, INC.
K833657	ANGIO-SET INTRAVENOUS CATH. SET	Dec 27, 1983	Substantially Equivalent	DESERET MEDICAL, INC.
K832558	RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV	Nov 28, 1983	Substantially Equivalent	DESERET MEDICAL, INC.
K833135	INTRACATH INTRAVENOUS CATHETER UNIT	Nov 21, 1983	Substantially Equivalent	PARKE-DAVIS CO.
K833092	DESERET ANGIO-GUIDE LARGE VEIN CATH.	Nov 21, 1983	Substantially Equivalent	WARNER-LAMBERT CO.
K833091	DESERET SUBCLAVIAN JUGULAR CATH-SET	Nov 21, 1983	Substantially Equivalent	WARNER-LAMBERT CO.
K832624	TOP VENULA I.V. CATHETER SET	Nov 21, 1983	Substantially Equivalent	TOP SURGICAL MANUFACTURERS CO.
K830541	INJECTION SEALING CAP 13791	Aug 08, 1983	Substantially Equivalent	QUINTON, INC.
K830972	I.V. CATHETER PLACEMENT UNIT POLYURETH	Apr 27, 1983	Substantially Equivalent	CRITIKON COMPANY,LLC
K830765	WINGED CATHETER	Mar 31, 1983	Substantially Equivalent	ABBOTT LABORATORIES
K830573	PRE VUE	Mar 29, 1983	Substantially Equivalent	TAUT, INC.
K830539	INTRAVASCULAR CATHETER SET	Mar 17, 1983	Substantially Equivalent	LAB-A-CATH CORP.
K823565	MULTI-LUMEN INTRAVENOUS CATHETER	Dec 16, 1982	Substantially Equivalent	MCPHERSON ENTERPRISES, INC.
K823351	CENTRAL VENOUS CATHETER	Dec 09, 1982	Substantially Equivalent	PLASMEDICS, INC.
K822776	TEFLON CANNULA	Nov 03, 1982	Substantially Equivalent	CARDIAC PACEMAKERS, INC.
K823017	INTRAVENOUS CATHETER PLACEMENT UNIT &	Nov 01, 1982	Substantially Equivalent	ACCESS DEVICES, INC.
K822023	DESERET SUBCLAVIAN JUGULAR CATH. SET	Jul 28, 1982	Substantially Equivalent	WARNER-LAMBERT CO.
K821929	SUBCLAVIAN	Jul 08, 1982	Substantially Equivalent	DNA MEDICAL, INC.
K821679	LEONARD/NORTON HYPERALIMENTATION CATHET.	Jul 02, 1982	Substantially Equivalent	NORTON PERFORMANCE PLASTICS CORP.
K821699	DESERET SUBCLAVIAN JUGULAR CATHETER SET	Jun 24, 1982	Substantially Equivalent	WARNER-LAMBERT CO.
K821577	DESERET ANGIO GUIDE	Jun 16, 1982	Substantially Equivalent	WARNER-LAMBERT CO.
K821372	DESERET INTRACATH INTRAVENOUS CATHETER	Jun 02, 1982	Substantially Equivalent	WARNER-LAMBERT CO.
K821371	DESERET SUBCLAVIAN JUGULAR CATHETER SET	Jun 02, 1982	Substantially Equivalent	WARNER-LAMBERT CO.
K813374	NUTRICATH	Mar 15, 1982	Substantially Equivalent	EXCO, INC.
K813396	VERSCHLUBSTOPFEN COMB-CLOSING STOPPER	Jan 12, 1982	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K813345	CRITIKON I.V. CATHETER PLACEMENT UNIT	Jan 12, 1982	Substantially Equivalent	CRITIKON COMPANY,LLC
K812137	B-D HEPARINIZED LONGDWEL I.V. CATHETER	Nov 06, 1981	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K812159	INTRAVASCULAR CATHETER	Aug 31, 1981	Substantially Equivalent	PIONEER VIGGO, INC.
K811171	VASCULON II I.V. CATHETER	May 27, 1981	Substantially Equivalent	PIONEER VIGGO, INC.
K803238	INTRAVASCULAR CATHETER	Apr 23, 1981	Substantially Equivalent	G.D. SEARLE AND CO.
K802918	ANTHRON CATHETER SET	Apr 21, 1981	Substantially Equivalent	NATIONAL CATHETER CO. DIV. MALLINCKRODT
K801537	START IT WITH & WITHOUT I.V. CATH. UNIT	Sep 19, 1980	Substantially Equivalent	PIONEER VIGGO, INC.
K801941	BURRON MICROCATH INTRA. CATH. PLACEMENTT	Aug 27, 1980	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K801575	L-CATH INTRAVENOUS PLACEMENT UNIT	Aug 20, 1980	Substantially Equivalent	LUTHER MEDICAL PRODUCTS, INC.
K801414	ERYTHROCATH INTRAVENOUS CATHETER PLA. U.	Aug 13, 1980	Substantially Equivalent	G.D. SEARLE AND CO.
K800786	INJECTION SITE, CODE NO. 3100	May 08, 1980	Substantially Equivalent	QUEST MEDICAL, INC.
K800525	MEDICAL COMPONENTS IV CATHETER	Apr 08, 1980	Substantially Equivalent	MEDICAL COMPONENTS, INC.
K791918	JELCO WINGED INTRAVASCULAR CATHETER	Oct 02, 1979	Substantially Equivalent	JELCO LABORATORIES
K790914	SILASTIC INTRAVENOUS CATHETER UNIT	Jul 03, 1979	Substantially Equivalent	DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K790967	CATHETER METAL HUB/RADIOPAQUE	Jun 27, 1979	Substantially Equivalent	JELCO LABORATORIES
K772011	WHOLEY OCCLUSION BALLOON CATHETER	Jun 15, 1979	Substantially Equivalent	COOK, INC.
K790968	CATHETER METAL HUB/NONRADIOPAQUE	Jun 11, 1979	Substantially Equivalent	JELCO LABORATORIES
K780350	I.V. START KIT	Mar 27, 1978	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780105	NEEDLE CONNECTING SET, BLUNT	Feb 21, 1978	Substantially Equivalent	ABBOTT LABORATORIES
K772354	I.V. CATHETER	Jan 31, 1978	Substantially Equivalent	NDM CORP.
K771381	IV CATHETER HUB	Oct 13, 1977	Substantially Equivalent	JELCO LABORATORIES
K771573	DUO-CATH FEMORAL	Sep 15, 1977	Substantially Equivalent	MEDICAL DEVICE LABORATORIES
K770751	CATHETERS, OVER-THE-NEEDLE	May 26, 1977	Substantially Equivalent	CUTTER LABORATORIES, INC.
K770510	CANNULA, INTRAVENOUS, TEFLON	May 10, 1977	Substantially Equivalent	SHERWOOD MEDICAL INDUSTRIES
K770511	CANNULA, INTRAVENOUS, HEPARINIZED	Apr 29, 1977	Substantially Equivalent	SHERWOOD MEDICAL INDUSTRIES
K770181	I.V. CATHETER PLACEMENT UNIT	Mar 30, 1977	Substantially Equivalent	AMERICAN VIGGO
K770403	CATHETER-THRU-NEEDLE DEVICE	Mar 16, 1977	Substantially Equivalent	ABBOTT LABORATORIES
K760319	KIT, CATHETER	Aug 11, 1976	Substantially Equivalent	JELCO LABORATORIES
K760163	CATHETER, INTRAVASCULAR (MEDICUT T)	Jul 20, 1976	Substantially Equivalent	SHERWOOD MEDICAL INDUSTRIES

FEI Numbers

This FDA classification entry is associated with 212 FEI numbers. Click on an entry to view related FDA registrations.

1000112877: 433 registrations

1000112968: 424 registrations

1000113359: 12 registrations

1000117748: 143 registrations

1000120555: 57 registrations

1000123180: 115 registrations

1000136269: 265 registrations

1000138054: 760 registrations

1000160458: 173 registrations

1000163068: 16 registrations

1000174591: 13 registrations

1000220862: 104 registrations

1000306068: 11 registrations

1000477110: 15 registrations

1000512168: 447 registrations

1000514656: 190 registrations

1000563940: 52 registrations

1000587249: 6 registrations

1018233: 409 registrations

1018470: 468 registrations

1035907: 28 registrations

1043214: 577 registrations

1219611: 13 registrations

1220477: 911 registrations

1220905: 13 registrations

1282497: 47 registrations

1319211: 63 registrations

1410248: 5 registrations

1417592: 699 registrations

1625425: 139 registrations

1710034: 25 registrations

1713468: 54 registrations

1721676: 747 registrations

1721686: 241 registrations

1820334: 521 registrations

1824619: 64 registrations

1921846: 275 registrations

1928237: 782 registrations

2011171: 834 registrations

2015691: 181 registrations

2024024: 189 registrations

2025816: 30 registrations

2243072: 162 registrations

2245270: 49 registrations

2246552: 325 registrations

2518902: 138 registrations

2523676: 144 registrations

2527072: 16 registrations

2648045: 124 registrations

2828: 68 registrations

3000206435: 390 registrations

3000247873: 52 registrations

3000268902: 58 registrations

3001124136: 59 registrations

3001236905: 677 registrations

3002468371: 157 registrations

3002558692: 135 registrations

3002601200: 3 registrations

3002806469: 63 registrations

3002806476: 19 registrations

3002806482: 2 registrations

3002806575: 91 registrations

3002806603: 114 registrations

3002806830: 41 registrations

3002806934: 112 registrations

3002807111: 309 registrations

3002807308: 31 registrations

3002807314: 432 registrations

3002807350: 12 registrations

3002807391: 147 registrations

3002807548: 9 registrations

3002807710: 11 registrations

3002807725: 16 registrations

3002808374: 14 registrations

3002808464: 16 registrations

3002879021: 31 registrations

3002902735: 417 registrations

3002963732: 68 registrations

3002974635: 25 registrations

3003040625: 290 registrations

3003058448: 327 registrations

3003076831: 367 registrations

3003169040: 3 registrations

3003184529: 3 registrations

3003205539: 14 registrations

3003282181: 15 registrations

3003382061: 13 registrations

3003418325: 774 registrations

3003442380: 17 registrations

3003560965: 24 registrations

3003674698: 69 registrations

3003737899: 262 registrations

3003752255: 6 registrations

3003775072: 22 registrations

3003807466: 54 registrations

3003895440: 12 registrations

3003902955: 9 registrations

3003910417: 2 registrations

3003915875: 145 registrations

3004111573: 356 registrations

3004129394: 3 registrations

3004134316: 17 registrations

3004187702: 1 registration

3004784537: 57 registrations

3004785273: 34 registrations

3005011024: 409 registrations

3005246939: 50 registrations

3005515211: 27 registrations

3005747797: 800 registrations

3005846326: 140 registrations

3005956311: 1 registration

3005987240: 63 registrations

3006003617: 43 registrations

3006066614: 519 registrations

3006082230: 372 registrations

3006097687: 17 registrations

3006260740: 216 registrations

3006425876: 120 registrations

3006621386: 4 registrations

3006846316: 6 registrations

3006942602: 5 registrations

3006950086: 268 registrations

3007207906: 22 registrations

3007616112: 2 registrations

3007836437: 41 registrations

3008002452: 202 registrations

3008307705: 125 registrations

3008403546: 40 registrations

3008410596: 8 registrations

3008496528: 12 registrations

3009211636: 67 registrations

3009291251: 68 registrations

3009380063: 216 registrations

3009750712: 39 registrations

3009758019: 1 registration

3010041511: 587 registrations

3010055973: 92 registrations

3010131137: 206 registrations

3010220595: 187 registrations

3010237023: 35 registrations

3010384323: 5 registrations

3010413216: 11 registrations

3010419931: 59 registrations

3010421104: 31 registrations

3010425778: 116 registrations

3010532612: 32 registrations

3010605677: 176 registrations

3010621964: 59 registrations

3010754844: 2 registrations

3010934635: 12 registrations

3011088743: 53 registrations

3011237770: 70 registrations

3011357022: 8 registrations

3011689956: 141 registrations

3012026312: 15 registrations

3012039263: 7 registrations

3012050423: 50 registrations

3012104670: 72 registrations

3012187635: 29 registrations

3012307300: 358 registrations

3012410077: 36 registrations

3012421607: 606 registrations

3012494290: 762 registrations

3012536737: 270 registrations

3012542015: 18 registrations

3012627824: 85 registrations

3012636179: 178 registrations

3012809732: 34 registrations

3013188547: 138 registrations

3013298431: 204 registrations

3013319212: 78 registrations

3013517171: 71 registrations

3013547822: 1 registration

3013557562: 654 registrations

3013561886: 55 registrations

3013764800: 172 registrations

3014270673: 3 registrations

3014389131: 9 registrations

3014656749: 53 registrations

3014663754: 10 registrations

3015058854: 133 registrations

3015173212: 285 registrations

3015309643: 267 registrations

3015550451: 87 registrations

3015724078: 4 registrations

3015859709: 148 registrations

3015997711: 72 registrations

3016261803: 13 registrations

3016678045: 154 registrations

3016727301: 7 registrations

3016904853: 78 registrations

3017129766: 1 registration

3020460367: 78 registrations

3021570645: 4 registrations

3022054170: 3 registrations

3023287212: 42 registrations

3026197505: 9 registrations

3026408938: 290 registrations

3030390308: 7 registrations

3030446844: 160 registrations

3030574705: 46 registrations

3030626857: 33 registrations

3030714660: 18 registrations

3030733800: 163 registrations

3031233007: 29 registrations

3031983053: 3 registrations

3033536319: 44 registrations

3033589330: 268 registrations

3035111606: 4 registrations

3036773433: 4 registrations

3036802567: 1 registration

3037918935: 6 registrations