Product Code: DQO FDA class 2 21 CFR 870.1200

Catheter, Intravascular, Diagnostic

Cardiovascular

The Intravascular Diagnostic Catheter is a cardiovascular device inserted into blood vessels to measure hemodynamic parameters such as pressure, flow, or oxygen content during diagnostic procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQO and it is regulated under 21 CFR 870.1200 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

500

FEI Numbers

210

Registration Numbers

211

Unique Applicants

204

Years Active

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Basic Information

Product Code: DQO
Device Class: FDA class 2
Regulation Number: 870.1200
Medical Specialty: Cardiovascular
Review Panel: CV
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 500 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252702	Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N	May 28, 2026	Substantially Equivalent	Bioptimal International Pte. , Ltd.
K254278	Arterial Pressure Monitoring Set/Tray	Mar 25, 2026	Substantially Equivalent	Spectrum Vascular
K250751	DualView Catheter	Jul 17, 2025	Substantially Equivalent	Terumo Corporation
K242966	Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter	Jan 31, 2025	Substantially Equivalent	Gentuity, LLC
K242420	pNOVUS 21 Microcatheter	Nov 12, 2024	Substantially Equivalent	Phenox, Ltd.
K233268	Impress Angiographic Catheter	May 22, 2024	Substantially Equivalent	Merit Medical Systems, Inc.
K233975	Zoom 6F Insert Catheters	Apr 02, 2024	Substantially Equivalent	Imperative Care, Inc.
K232536	Soldier Microcatheter	Feb 23, 2024	Substantially Equivalent	Embolx, Inc.
K232573	INFINITI Ambi Angiographic Catheter	Nov 21, 2023	Substantially Equivalent	Cordis US Corp
K230620	Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter	Aug 08, 2023	Substantially Equivalent	Gentuity, LLC
K231293	Drakon and Sequre® Microcatheters	Jun 01, 2023	Substantially Equivalent	Accurate Medical Therapeutics
K230411	Dragonfly OpStar Imaging Catheter	Apr 14, 2023	Substantially Equivalent	ABBOTT MEDICAL
K221279	pNOVUS 21 Microcatheter	Nov 28, 2022	Substantially Equivalent	Phenox, Ltd.
K213666	NuCath Wedge Pressure Catheter	Oct 06, 2022	Substantially Equivalent	Pfm Medical, Inc.
K221470	Langston dual lumen catheter	Jun 17, 2022	Substantially Equivalent	Vascular Solutions, LLC
K212977	SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands	Feb 17, 2022	Substantially Equivalent	Cordis Corporation
K211078	Progreat Lambda	Dec 21, 2021	Substantially Equivalent	Terumo Clinical Supply Co., Ltd.
K203487	Drakon and Sequre Microcatheters	Dec 11, 2020	Substantially Equivalent	Accurate Medical Therapeutics, Ltd.
K202797	Drakon and Sequre Microcatheters	Oct 23, 2020	Substantially Equivalent	Accurate Medical Therapeutics, Ltd.
K193647	Superpipe Angiographic Catheter	Jul 29, 2020	Substantially Equivalent	Suzhou Hengrui Disheng Medical Co., Ltd.
K192267	ILUMIEN System with AptiVue Software version D.3	Dec 17, 2019	Substantially Equivalent	ABBOTT MEDICAL
K192122	Trevo Trak 21 Microcatheter	Nov 22, 2019	Substantially Equivalent	Stryker
K192019	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	Nov 08, 2019	Substantially Equivalent	ABBOTT MEDICAL
K190126	Bendit2.7 Steerable Microcatheter	Aug 22, 2019	Substantially Equivalent	Bend IT Technologies, Ltd.
K191608	Impress Angiographic Catheter	Jul 16, 2019	Substantially Equivalent	Merit Medical Systems, Inc.
K181722	Polyethylene Catheter	Mar 22, 2019	Substantially Equivalent	Cook Incorporated
K180846	Arterial Pressure Monitoring Set/Tray	Dec 19, 2018	Unknown	Cook Incorporated
K180792	Arterial Pressure Monitoring Set/Tray	Nov 30, 2018	Substantially Equivalent	Cook Incorporated
K180286	Polyethylene Catheter	Oct 26, 2018	Substantially Equivalent	Cook Incorporated
K180054	Royal Flush Plus High-Flow Catheter	Oct 05, 2018	Substantially Equivalent	Cook Incorporated
K181836	4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters	Aug 08, 2018	Substantially Equivalent	Cordis, A Cardinal Health Company
K173762	AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters	Jul 18, 2018	Substantially Equivalent	AngioDynamics, Inc.
K180677	Surefire Spark Infusion System	Apr 03, 2018	Substantially Equivalent	Surefire Medical, Inc.
K172635	High-Flo Silver Polyethylene Catheter	Apr 03, 2018	Substantially Equivalent	Cook Incorporated
K173430	SeQure® NF and SeQure® Microcatheters	Jan 26, 2018	Substantially Equivalent	Accurate Medical Therapeutics, Ltd.
K171264	Royal Flush Catheter	Jan 25, 2018	Substantially Equivalent	Cook Incorporated
K170544	Langston dual lumen catheter	Nov 17, 2017	Substantially Equivalent	Vascular Solutions, Inc.
K173289	Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter	Nov 15, 2017	Substantially Equivalent	Cook Incorporated
K170223	Progreat	Jul 21, 2017	Substantially Equivalent	Ashitaka Factory of Terumo Corporation
K162448	White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter	May 26, 2017	Substantially Equivalent	Cook Incorporated
K171355	Surefire Precision Infusion System	May 17, 2017	Substantially Equivalent	Surefire Medical, Inc.
K161596	Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters	Apr 28, 2017	Substantially Equivalent	AngioDynamics, Inc.
K170406	Plato MICROCATH 27B Microcatheter	Apr 18, 2017	Substantially Equivalent	Scientia Vascular, LLC
K162789	Foresight Intracardiac Echocardiology (ICE) System	Mar 28, 2017	Substantially Equivalent	Conavi Medical, Inc.
K160660	Medline Waste Station	Jan 19, 2017	Substantially Equivalent	Medline Industries, Inc.
K163141	NAMIC ClearaCIL Contrast Injection Lines	Jan 06, 2017	Substantially Equivalent	AngioDynamics, Inc.
K161822	Torcon NB Advantage Catheters	Oct 27, 2016	Substantially Equivalent	Cook Incorporated
K161287	DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak	Aug 19, 2016	Unknown	Medtronic Vascular
K160662	Surefire Infusion System	Mar 11, 2016	Substantially Equivalent	Surefire Medical, Inc.
K153125	IntraNovo Microcatheter	Jan 13, 2016	Substantially Equivalent	Texasmedical Technologies, Inc.
K151126	Foresight Intracardiac Echocardiography (ICE) System	Dec 18, 2015	Substantially Equivalent	Colibri Technologies, Inc.
K152605	Impulse Angiographic Catheter, Expo Angiographic Catheter	Oct 29, 2015	Substantially Equivalent	Boston Scientific Corporation
K150232	Radifocus Optitorque Angiographic Catheter	Oct 19, 2015	Substantially Equivalent	Ashitaka Factory of Terumo Corp.
K151724	AngioDynamics Mariner Angiographic Catheters	Oct 14, 2015	Substantially Equivalent	AngioDynamics, Inc.
K143398	Plato MICROCATH 27B Microcatheter	Jun 26, 2015	Substantially Equivalent	Scientia Vascular, LLC
K143604	Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters	Jun 25, 2015	Substantially Equivalent	Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S
K142817	IntraNovo 25 Microcatheter	Apr 23, 2015	Substantially Equivalent	Texasmedical Technologies, Inc.
K140356	SUMMED HIGH PRESSURE LINE	Mar 20, 2015	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.
K143588	Surefire Infusion System 021	Jan 12, 2015	Substantially Equivalent	Surefire Medical, Inc.
K133130	BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER	Jan 09, 2015	Substantially Equivalent	Cook, Inc.
K141453	ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER	Sep 19, 2014	Substantially Equivalent	Lightlab Imaging, Inc.
K141769	OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER	Aug 18, 2014	Substantially Equivalent	Lightlab Imaging, Inc.
K131770	PRESSURE CONNECTING TUBE	Feb 26, 2014	Substantially Equivalent	Shenzhen Ant Hi-Tech Industrial Co., Ltd.
K131437	MODIFIED CONCENTRIC MICROCATHETER	Oct 11, 2013	Substantially Equivalent	Concentric Medical, Inc.
K123818	URSA ANGIOGRAPHIC CATHETER	Mar 04, 2013	Substantially Equivalent	Curative Medical Technology, Inc.
K122937	SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)	Dec 14, 2012	Substantially Equivalent	Cook, Inc.
K121694	IMAGER II ANGIOGRAPHIC CATHETER	Sep 14, 2012	Substantially Equivalent	Boston Scientific Corp
K120008	MEDLINE HIGH PRESSURE INJECTION TUBING	Aug 17, 2012	Substantially Equivalent	Medline Industries, Inc.
K120917	HEADWAY DUO MICROCATHETER	Aug 02, 2012	Substantially Equivalent	MicroVention, Inc.
K121734	PLATO MICROCATH 27 MICROCATHETER	Jul 30, 2012	Substantially Equivalent	Scientia Vascular, LLC
K121954	NMI MICROCATHETER	Jul 17, 2012	Substantially Equivalent	Navilyst Medical, Inc.
K113335	HEARTRAIL III GUIDING CATHETER	Jul 16, 2012	Substantially Equivalent	Terumo Corporation
K113819	MONGOOSE ANGIOGRAPHIC CATHETER	Jul 11, 2012	Substantially Equivalent	Pediacath, Inc.
K121677	SUREFIRE HI-FLOW MICROCATHETER	Jun 14, 2012	Substantially Equivalent	Surefire Medical, Inc.
K120495	IMPULSE AND EXPO ANGIOGRAPHIC CATHETER	May 21, 2012	Substantially Equivalent	Boston Scientific Corp
K112452	ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS	Mar 30, 2012	Substantially Equivalent	AngioDynamics, Inc.
K120893	IMAGER II ANGIOGRAPHIC CATHETERS	Mar 29, 2012	Substantially Equivalent	Boston Scientific Corp
K113260	MODIFIED CONCENTIRC MICROCATHETER	Mar 09, 2012	Substantially Equivalent	Concentric Medical, Inc.
K113737	SUREFIRE GUIDE SHEATH	Feb 23, 2012	Substantially Equivalent	Surefire Medical, Inc.
K113638	NMI 2.8 MICROCATHETER	Jan 05, 2012	Substantially Equivalent	Navilyst Medical, Inc.
K102633	BIOTEQ ANGIOGRAPHIC CATHETER	Sep 09, 2011	Substantially Equivalent	Bioteque Corp.
K112124	MICROCATHETER	Aug 19, 2011	Substantially Equivalent	Navilyst Medical, Inc.
K111619	MODIFIED CONCENTRIC MICROCATHETER	Jul 06, 2011	Substantially Equivalent	Concentric Medical, Inc.
K110643	MERIT MARQUIS FLOW SWITCH	Jul 01, 2011	Substantially Equivalent	Merit Medical Systems, Inc.
K110459	SUREFIRE INFUSION CATHETER SYSTEM	Jun 24, 2011	Substantially Equivalent	Surefire Medical, Inc.
K110103	EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER	Feb 11, 2011	Substantially Equivalent	Edwards Lifesciences, LLC
K101625	COHEN CROSSOVER CATHETER	Jul 19, 2010	Substantially Equivalent	Vascular Solutions, Inc.
K101669	THERMODILUTION CATHETER	Jul 01, 2010	Substantially Equivalent	Biosensors Intl. Pte. , Ltd.
K101239	VIEWFLEX PLUS ICE CATHETER	Jun 02, 2010	Substantially Equivalent	St Jude Medical
K093004	IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING	Feb 12, 2010	Substantially Equivalent	Merit Medical Systems, Inc.
K090427	URSA ANGIOGRAPHIC CATHETER	Jan 29, 2010	Substantially Equivalent	Curative Medical Technology, Inc.
K092118	ANGIOGRAPHIC CATHETER, MODEL ANGIOS	Jan 13, 2010	Substantially Equivalent	Oscor, Inc.
K083384	THERMODILUTION CATHETER	Jan 05, 2010	Substantially Equivalent	Biosensors Intl. Pte. , Ltd.
K092702	MICRUS MICROCATHETER, MODEL COURIER 270	Nov 20, 2009	Substantially Equivalent	Micrus Endovascular Corporation
K091780	GUIDED MEASUREMENT CATHETER (GMC)	Oct 16, 2009	Substantially Equivalent	Mediguide, Ltd.
K092372	HEARTRAIL III GUIDING CATHETER	Sep 11, 2009	Substantially Equivalent	Terumo Corp.
K091961	MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047	Jul 30, 2009	Substantially Equivalent	Concentric Medical, Inc.
K083922	MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00	May 06, 2009	Substantially Equivalent	Micrus Endovascular Corporation
K090276	ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM	Feb 19, 2009	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K090040	RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)	Feb 06, 2009	Substantially Equivalent	Terumo Medical Corp.
K081846	GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951	Jan 28, 2009	Substantially Equivalent	Vascular Solutions, Inc.
K082736	RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER	Sep 24, 2008	Substantially Equivalent	Terumo Medical Corp.
K073585	INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905	Apr 17, 2008	Substantially Equivalent	Vascular Solutions, Inc.
K073200	GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582	Feb 01, 2008	Substantially Equivalent	Vascular Solutions, Inc.
K072796	MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044	Dec 18, 2007	Substantially Equivalent	Concentric Medical, Inc.
K072526	MICRUS COURIER ENZO MICROCATHETER 0.0190	Oct 05, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K071196	DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS	Sep 06, 2007	Substantially Equivalent	Coeur, Inc.
K070456	MICRUS COURIER ENZO MICROCATHETER 0.017	May 24, 2007	Substantially Equivalent	Micrus Endovascular Corporation
K063784	DYE MANAGEMENT SYSTEM	Apr 16, 2007	Substantially Equivalent	Icu Medical, Inc.
K070011	IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER	Mar 20, 2007	Substantially Equivalent	Irvine Biomedical,Inc.(Ibi)
K062877	TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230	Jan 18, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K062627	INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905	Jan 05, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K063312	MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942	Nov 30, 2006	Substantially Equivalent	Boston Scientific Corp
K061733	ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER	Aug 24, 2006	Substantially Equivalent	AngioDynamics, Inc.
K062126	EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135	Aug 09, 2006	Substantially Equivalent	Biosphere Medical, Inc.
K061963	MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00	Aug 04, 2006	Substantially Equivalent	Micrus Endovascular Corporation
K060010	NAUTIFLUX	Aug 04, 2006	Substantially Equivalent	Sedat
K061565	LANGSTON DUAL LUMEN CATHETER	Aug 02, 2006	Substantially Equivalent	Vascular Solutions, Inc.
K052908	INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5	Jun 23, 2006	Substantially Equivalent	Infraredx, Inc.
K060116	MICRUS COURIER MICROCATHETERS	May 12, 2006	Substantially Equivalent	Micrus Endovascular Corporation
K060175	ISIGHT IMAGING CATHETER, MODEL 38986	Mar 24, 2006	Substantially Equivalent	Boston Scientific Corp
K052637	THEROX INFUSION CATHETER, MODEL INCA-1	Mar 08, 2006	Substantially Equivalent	Therox, Inc.
K053171	MERIT IMPRESS DIAGNOSTIC CATHETER	Jan 19, 2006	Substantially Equivalent	Merit Medical Systems, Inc.
K052865	HOSPIRA CATH LAB CONVENIENCE KITS	Dec 22, 2005	Substantially Equivalent	Icu Medical, Inc.
K051561	ASAHI ANGIOGRAPHIC CATHETER	Nov 02, 2005	Substantially Equivalent	Asahi Intecc Co., Ltd.
K050863	IMAGER II ANGIOGRAPHIC CATHETER	Sep 02, 2005	Substantially Equivalent	Boston Scientific Corp
K051395	LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER	Jun 24, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K050371	MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER	Jun 07, 2005	Substantially Equivalent	Medrad, Inc.
K050684	ATLANTIS PV	May 20, 2005	Substantially Equivalent	Boston Scientific Corp
K050168	LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER	May 18, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K050577	ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014	Mar 30, 2005	Substantially Equivalent	Boston Scientific Corp
K042685	METRICATH SYSTEM	Nov 18, 2004	Substantially Equivalent	Angiometrx, Inc.
K041909	VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)	Sep 23, 2004	Substantially Equivalent	Vascular Solutions, Inc.
K041123	RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703	Aug 26, 2004	Unknown	Kerberos Proximal Solutions, Inc.
K034043	H-FLOW VALVE	Jun 30, 2004	Substantially Equivalent	Elcam Medical Acal
K040830	PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS	Jun 18, 2004	Substantially Equivalent	NuMED, Inc.
K041291	RINSPIRATION SYSTEM	May 21, 2004	Substantially Equivalent	Kerberos Proximal Solutions, Inc.
K040776	ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975	Apr 29, 2004	Substantially Equivalent	Boston Scientific Corp
K032888	CREATION NM DIAGNOSTIC CATHETERS	Feb 24, 2004	Substantially Equivalent	Neich Medical (Shenzhen) Company Limited
K033583	PROGREAT	Dec 12, 2003	Substantially Equivalent	Terumo Medical Corp.
K031599	CD LEYCOM PRESSURE/VOLUME CATHETERS	Dec 09, 2003	Substantially Equivalent	Cd Leycom BV
K031485	RINSPIRATION SYSTEM	Sep 25, 2003	Substantially Equivalent	Kerberos Proximal Solutions
K032624	MICRUS MICROCATHETER	Sep 10, 2003	Substantially Equivalent	Micrus Corp.
K032376	ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER	Aug 26, 2003	Substantially Equivalent	AngioDynamics, Inc.
K024000	METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER	Jun 26, 2003	Substantially Equivalent	Angiometrx, Inc.
K023591	ULTRA HIGH PRESSURE INJECTOR LINES	Jun 18, 2003	Substantially Equivalent	Deroyal Industries, Inc.
K022004	CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1	Mar 12, 2003	Substantially Equivalent	Biosensors International-USA
K024126	CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT	Jan 14, 2003	Substantially Equivalent	Abbott Laboratories
K023681	RENEGADE STC 18 MICROCATHETER	Nov 26, 2002	Substantially Equivalent	Boston Scientific Corp
K022621	BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER	Sep 04, 2002	Substantially Equivalent	Boston Scientific Corp
K021283	GUIDANT BALLOON CATHETER, SEVERAL MODELS	May 02, 2002	Substantially Equivalent	Guidant Corp.
K021015	ACIST PLUS 4 ANGIOGRAPHIC CATHETER	Apr 26, 2002	Substantially Equivalent	Acist Medical Systems
K020890	SPYGLASS 4 FR ANGIOGRAPHICY CATHETER	Apr 17, 2002	Substantially Equivalent	St Jude Medical
K020316	CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU	Mar 20, 2002	Substantially Equivalent	Cordis Corp.
K012983	ACIST 4 FRENCH ANGIOGRAPHIC CATHETER	Mar 13, 2002	Substantially Equivalent	Acist Medical Systems, Inc.
K014054	EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL	Mar 08, 2002	Substantially Equivalent	Edwards Lifesciences, LLC
K020012	MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER	Jan 29, 2002	Substantially Equivalent	Boston Scientific/Medi-Tech
K012749	BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664	Jan 24, 2002	Substantially Equivalent	Biocardia, Inc.
K011664	IMAGER II ANGIOGRAPHIC CATHETER	Sep 07, 2001	Substantially Equivalent	Boston Scientific/Medi-Tech
K003288	ORIGEN DUAL LUMEN CATHETER	Jun 08, 2001	Substantially Equivalent	Origen Biomedical, Inc.
K003105	BIOSPHERE MEDICAL INFUSION CATHETER	May 22, 2001	Substantially Equivalent	Biosphere Medical
K011217	CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT	May 16, 2001	Substantially Equivalent	Abbott Laboratories
K003086	CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008	May 16, 2001	Substantially Equivalent	Concentric Medical, Inc.
K003020	CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER	May 11, 2001	Substantially Equivalent	Cd Leycom BV
K010707	ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975	Mar 29, 2001	Substantially Equivalent	Boston Scientific, Target
K002254	COOK PRESSURE MONITORING CATHETER	Mar 16, 2001	Substantially Equivalent	Cook, Inc.
K003938	TRAK BACK II	Jan 18, 2001	Substantially Equivalent	Jomed, Inc.
K003901	ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER	Jan 17, 2001	Substantially Equivalent	AngioDynamics, Inc.
K003902	MULTITRACK ANGIOGRAPHIC CATHETER	Jan 11, 2001	Substantially Equivalent	NuMED, Inc.
K001578	ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER	Oct 13, 2000	Substantially Equivalent	AngioDynamics, Inc.
K000825	4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER	Sep 21, 2000	Substantially Equivalent	Medi-Dyne, Inc.
K002416	GOLDEN-RULE SCALING CATHETER	Sep 11, 2000	Substantially Equivalent	Medical Device Technologies, Inc.
K000743	BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020	Sep 06, 2000	Substantially Equivalent	Boston Scientific Scimed, Inc.
K000820	AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700	Jun 05, 2000	Substantially Equivalent	Endosonics Corp.
K000579	TEMPO AQUA ANGIOGRAPHIC CATHETER	May 03, 2000	Substantially Equivalent	Cordis Corp.
K000956	MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS	Apr 21, 2000	Substantially Equivalent	Boston Scientific Scimed, Inc.
K000659	MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT	Mar 29, 2000	Substantially Equivalent	Merit Medical Systems, Inc.
K993694	MIKRO-TIP ANGIOGRAPHIC CATHETER	Mar 01, 2000	Substantially Equivalent	Millar Instruments, Inc.
K990173	PATHFINDER II ANGIOGRAPHIC CATHETER	Dec 21, 1999	Substantially Equivalent	Maxxim Medical
K992631	ACUNAV DIAGNOSTIC ULTRASOUND CATHETER	Dec 15, 1999	Substantially Equivalent	Acuson Corp.
K992347	CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS	Oct 08, 1999	Substantially Equivalent	Cordis Corp.
K992123	SCIMED IMPULSE ANGIOGRAPHIC CATHETERS	Aug 23, 1999	Substantially Equivalent	Boston Scientific Scimed, Inc.
K992051	RADIFOCUS OPTITORQUE	Aug 10, 1999	Substantially Equivalent	Terumo Medical Corp.
K984627	AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER	Jul 27, 1999	Substantially Equivalent	Arterial Vascular Engineering, Inc.
K992142	SCIMED ANGIOGRAPHIC CATHETERS	Jul 21, 1999	Substantially Equivalent	Scimed
K991673	CORDIS TEMPO ANGIOGRAPHY CATHETER	May 26, 1999	Substantially Equivalent	Cordis Corp.
K984258	NEUROVASX SUB-MICROINFUSION CATHETER	Feb 11, 1999	Substantially Equivalent	Neuro Vasx, Inc.
K980973	MEDTRONIC ANGIOGRAPHIC CATHETER	Dec 10, 1998	Substantially Equivalent	Medtronics Interventional Vascular
K971616	BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)	Nov 04, 1998	Substantially Equivalent	Data Sciences Intl., Inc.
K982299	SPYGLASS 5 FR ANGIOGRAPHIC CATHETER	Oct 19, 1998	Substantially Equivalent	Daig Corp.
K974774	ENVY GUIDING CATHETER	Oct 16, 1998	Substantially Equivalent	Cook, Inc.
K981788	SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER	Aug 18, 1998	Substantially Equivalent	Scimed Life Systems, Inc.
K982077	SELECTOR DIAGNOSTIC CATHETER	Aug 11, 1998	Substantially Equivalent	Boston Scientific Scimed, Inc.
K981441	HEART CATH TRAY, STERILE, DISPOSABLE	Jul 10, 1998	Substantially Equivalent	Trinity Laboratories, Inc.
K980575	SITESEER ANGIOGRAPHIC CATHETER	May 15, 1998	Substantially Equivalent	C.R. Bard, Inc.
K974559	SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS	Feb 23, 1998	Substantially Equivalent	Scimed Life Systems, Inc.
K973401	TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)	Nov 18, 1997	Substantially Equivalent	Cordis Corp.
K964210	RETRIEVER II	Oct 31, 1997	Substantially Equivalent	Target Therapeutics
K963335	HARMAC BALLOON WEDGE PRESSURE CATHETER	Oct 16, 1997	Substantially Equivalent	Harmac Medical Products, Inc.
K962829	HARMAC BALLOON ANGIOGRAPHIC CATHETER	Oct 16, 1997	Substantially Equivalent	Harmac Medical Products, Inc.
K965112	MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS	Oct 10, 1997	Unknown	Medline Industries, Inc.
K970854	5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER	Sep 30, 1997	Substantially Equivalent	Cordis Corp.
K970207	MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS	Jul 31, 1997	Substantially Equivalent	Boston Scientific Corp
K971607	MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS	Jul 24, 1997	Substantially Equivalent	Boston Scientific Corp
K971646	4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER	Jul 14, 1997	Substantially Equivalent	Cordis Corp.
K971034	USCI MAINSTAY GUIDING CATHETER	May 28, 1997	Substantially Equivalent	C.R. Bard, Inc.
K970469	EVT ANGIOSCALE ANGIOGRAPHIC CATHETER	May 08, 1997	Substantially Equivalent	Guidant Cardiac and Vascular Surgery
K964033	3F ANGIOPTIC ANGIOGRAPHIC CATHETER	May 06, 1997	Substantially Equivalent	AngioDynamics, Inc.
K965249	SPYGLASS ANGIOGRAPHIC CATHETER	Feb 21, 1997	Substantially Equivalent	Daig Corp.
K964859	SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS	Feb 10, 1997	Substantially Equivalent	Scimed Life Systems, Inc.
K964331	ASC HIGH PRESSURE BRAIDED TUBES	Jan 13, 1997	Substantially Equivalent	Adam Spencer Corp.
K963092	MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER	Jan 13, 1997	Substantially Equivalent	Adam Spencer Corp.
K960056	USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC	Oct 23, 1996	Substantially Equivalent	C.R. Bard, Inc.
K961499	LAGUNA SOFTIP DIAGNOSTIC CATHETERS	Oct 17, 1996	Substantially Equivalent	Boston Scientific Scimed, Inc.
K962805	SPYGLASS ANGIOGRAPHIC CATHETER	Oct 15, 1996	Substantially Equivalent	Daig Corp.
K962759	4F NYLEX ANGIOGRAPHIC CATHETER	Oct 10, 1996	Substantially Equivalent	Cordis Corp.
K960806	TURBO TRACKER	May 02, 1996	Substantially Equivalent	Target Therapeutics
K960975	1-4F INFINITI ANGIOGRAPHIC CATHETER	Apr 02, 1996	Substantially Equivalent	Cordis Corp.
K960070	NUMED ATRIOSEPTOSTOMY CATHETER	Apr 02, 1996	Substantially Equivalent	NuMED, Inc.
K960801	SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)	Mar 29, 1996	Substantially Equivalent	North American Instrument Corp.
K955485	BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS	Feb 23, 1996	Substantially Equivalent	B.Braun Medical, Inc.
K955111	MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER	Jan 31, 1996	Substantially Equivalent	Adam Spence Corp.
K952984	MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)	Jan 29, 1996	Substantially Equivalent	Map Medical Equipment, Inc.
K954423	ANGIOPTIC ANGIOGRAPHIC CATHETER	Dec 01, 1995	Substantially Equivalent	AngioDynamics, Inc.
K952773	MIKRO-TIP ANGIOGRAPHIC CATHETER	Nov 07, 1995	Substantially Equivalent	Millar Instruments, Inc.
K950398	CATHETER, BALLOON TYPE	Oct 05, 1995	Substantially Equivalent	Interventional Therapeutics Corp.
K950440	DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD	Sep 15, 1995	Substantially Equivalent	J-Lloyd Medical, Inc.
K953114	EVOLUTION MICROCATHETER	Sep 12, 1995	Substantially Equivalent	Boston Scientific Corp
K950882	BRAUN SELECTIVE ANGIOGRAPHIC CATHETER	Aug 17, 1995	Substantially Equivalent	B.Braun Medical, Inc.
K950910	TRANSIT-2 INFUSION CATHETER	Aug 08, 1995	Substantially Equivalent	Cordis Neurovascular, Inc.
K951720	SCIMED EXPO ANGIOGRAPHIC CATHETER	Jun 22, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K942927	0.035 IN. WISE WIRE	Jun 13, 1995	Substantially Equivalent	Boston Scientific Corp
K950855	ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS	May 30, 1995	Substantially Equivalent	Adam Spence Corp.
K950909	TRANSIT-2 INFUSION CATHETER	May 16, 1995	Substantially Equivalent	Cordis Neurovascular, Inc.
K950731	SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER	Apr 05, 1995	Substantially Equivalent	Scimed Life Systems, Inc.
K944284	CONTROL	Mar 03, 1995	Substantially Equivalent	Daig Corp.
K935985	DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION	Dec 21, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K941978	HIGH PRESSURE TUBING	Dec 13, 1994	Substantially Equivalent	Abbott Laboratories
K943192	SCIMED CHOICE(TM) PTCA GUIDE WIRE	Nov 22, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K943739	SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER	Nov 15, 1994	Substantially Equivalent	Mallinckrodt Medical
K932141	CARDIAC CATHETERIZATION KIT	Sep 22, 1994	Substantially Equivalent	Abbott Laboratories
K942939	CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM	Aug 31, 1994	Substantially Equivalent	Cordis Corp.
K942231	MICROVIEW II/MICRORAIL II CATHETERS	Aug 01, 1994	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K936282	TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)	Jul 18, 1994	Substantially Equivalent	Cordis Neurovascular, Inc.
K931560	CARDIAC CATHETERIZATION TRAY	Jul 11, 1994	Unknown	Clinipad Corp.
K922455	EVERT-O-CATH CATHETER	Jul 07, 1994	Substantially Equivalent	American Biomaterials Corp.
K942329	HAND CONTROLLED SYRINGE	Jun 20, 1994	Substantially Equivalent	Abbott Laboratories
K942482	PRESSURE MONITORING EXTENSION	Jun 14, 1994	Substantially Equivalent	Surgical Technologies, Inc.
K941254	DYE MANAGEMENT SYSTEM	Jun 13, 1994	Substantially Equivalent	Abbott Laboratories
K936260	TRANSIT INFUSION CATHETER	May 31, 1994	Substantially Equivalent	Cordis Corp.
K935403	WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD	May 12, 1994	Substantially Equivalent	J-Lloyd Medical, Inc.
K934541	SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION	May 12, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K935402	ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD	Apr 26, 1994	Substantially Equivalent	J-Lloyd Medical, Inc.
K934581	SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS	Mar 31, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K925813	DIAGNOSTIC INTRAVASCULAR CATHETER	Mar 23, 1994	Substantially Equivalent	Target Therapeutics
K935654	SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH	Feb 22, 1994	Substantially Equivalent	Scimed Life Systems, Inc.
K931629	CARAPACE ANGIOGRAPHY TRAYS	Dec 06, 1993	Substantially Equivalent	Carapace, Inc.
K930081	OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR	Nov 04, 1993	Substantially Equivalent	Ohmeda Monitoring Systems
K933700	DYE MANAGEMENT SYSTEM	Nov 03, 1993	Substantially Equivalent	Abbott Laboratories
K931479	SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER	Oct 06, 1993	Substantially Equivalent	Mallinckrodt Medical
K931833	MODIFIED LUER	Sep 28, 1993	Substantially Equivalent	Medi-Dyne, Inc.
K932218	CARDIAC CATH OR ANGIOGRAPHIC TRAYS	Aug 27, 1993	Unknown	Associated Medical Products Co.
K932420	SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING	Aug 17, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K926243	ANGIOGRAPHIC CATHETER	Aug 16, 1993	Substantially Equivalent	Target Therapeutics
K932542	SCIMED 6F ANGIOGRAPHIC CATHETER	Aug 11, 1993	Substantially Equivalent	Scimed Life Systems, Inc.
K930694	MEDI-DYNE ANGIOGRAPHIC CATHETER	Aug 02, 1993	Substantially Equivalent	Medi-Dyne, Inc.
K932092	USCI ANGIOGRAPHIC CATHETER	Jul 29, 1993	Substantially Equivalent	C.R. Bard, Inc.
K930232	CVIS INSIGHT IMAGING GUIDE CATHETER	Jul 21, 1993	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K925632	BALT GUIDING CATHETER	Jun 29, 1993	Substantially Equivalent	Target Therapeutics
K924922	CVIS INSIGHT IMAGING CATHETER	Jun 29, 1993	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K922891	CORDIS 7 FRENCH THRULUMEN CATHETER	Jun 23, 1993	Substantially Equivalent	Cordis Corp.
K926003	SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER	Jun 07, 1993	Substantially Equivalent	Schneider Intl., Ltd.
K930311	CVIS LONGVIEW	Jun 02, 1993	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K930479	NYLEX CATHETERS	Apr 21, 1993	Substantially Equivalent	Cordis Corp.
K921649	RETRIEVER 10	Mar 11, 1993	Substantially Equivalent	Target Therapeutics
K922552	MORSE(R) ANGIOGRAPHIC CATHETERS	Mar 03, 1993	Substantially Equivalent	North American Instrument Corp.
K922101	ANGIOGRAPHIC CATHETER -- MODIFICATION	Feb 12, 1993	Substantially Equivalent	Interventional Therapeutics Corp.
K920873	WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD	Jan 14, 1993	Substantially Equivalent	J-Lloyd Medical, Inc.
K920870	ANGIOGRAPHIC BALLOON CATHETER BY J LLOYD	Jan 07, 1993	Substantially Equivalent	J-Lloyd Medical, Inc.
K923699	DIAGNOSTIC INTRAVASCULAR CATHETER	Dec 21, 1992	Substantially Equivalent	Applied Vascular
K922484	COBE SAMPLING SITE	Dec 03, 1992	Substantially Equivalent	Cobe Cardiovascular, Inc.
K922105	USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING	Nov 17, 1992	Substantially Equivalent	C.R. Bard, Inc.
K921845	INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT	Nov 10, 1992	Substantially Equivalent	Becton Dickinson Vascular Access, Inc.
K923480	SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA	Oct 06, 1992	Substantially Equivalent	Scimed Life Systems, Inc.
K915726	PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH	Sep 21, 1992	Substantially Equivalent	Baxter Healthcare Corp
K921310	CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER	Sep 17, 1992	Substantially Equivalent	Cordis Corp.
K922254	LUKENS 2-0 BRAIDED SILK SUTURES	Sep 01, 1992	Substantially Equivalent	Quinton, Inc.
K920980	USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT	Aug 24, 1992	Substantially Equivalent	C.R. Bard, Inc.
K912270	POLYCATH #WMC-900	Aug 05, 1992	Substantially Equivalent	Worldwide Medical
K921879	CBIS CATHETER PULL-BACK DEVICE	Jul 16, 1992	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K915351	SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER	Jun 29, 1992	Substantially Equivalent	Medtronics Interventional Vascular
K914299	CARDIAC CATHERIZATION KIT	Jun 03, 1992	Substantially Equivalent	Abbott Laboratories
K915498	CORDIS ANGIOGRAPHIC DOPPLER CATHER	Apr 17, 1992	Substantially Equivalent	Cordis Corp.
K920408	DESERET GUIDEWIRE INTRODUCER III	Apr 07, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920407	DESERET GUIDEWIRE INTRODUCER II	Apr 07, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K915836	CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS	Feb 11, 1992	Substantially Equivalent	Cordis Corp.
K915414	TERUMO ANGIOGTAPHIC CATHETER	Feb 04, 1992	Substantially Equivalent	Terumo Medical Corp.
K915136	ATRAUMATIC TIP ANGIOGRAPHIC CATHETER	Jan 27, 1992	Substantially Equivalent	Exonix Research Corp.
K913094	DISPOSABLE SLIDE VALVE MANIFOLD	Jan 27, 1992	Substantially Equivalent	Professional Medical Services
K911270	LEOCOR GUIDING CATHETER	Jan 17, 1992	Substantially Equivalent	Leocor, Inc.
K914208	MERIT DISPOSAL DEPOT(TM)	Dec 18, 1991	Substantially Equivalent	Merit Medical Systems, Inc.
K914199	ANGIOGRAPHIC SOFT TIP CATHETER	Dec 18, 1991	Substantially Equivalent	E-Z-Em, Inc.
K912532	ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH	Dec 11, 1991	Substantially Equivalent	Interventional Therapeutics Corp.
K914067	RETRIEVAL DEVICE	Dec 10, 1991	Substantially Equivalent	Target Therapeutics
K914009	SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER	Dec 06, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K914128	CONNECTING SET	Nov 27, 1991	Substantially Equivalent	Procedure Products, Inc.
K913871	FLOSWITCH(R) HP	Nov 25, 1991	Substantially Equivalent	Boston Scientific Corp
K914312	SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS	Nov 22, 1991	Substantially Equivalent	Scimed Life Systems, Inc.
K913682	MERIT CUSTOM KIT	Nov 15, 1991	Substantially Equivalent	Merit Medical Systems, Inc.
K912477	ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION	Nov 05, 1991	Substantially Equivalent	Interventional Therapeutics Corp.
K913397	MEGA ANGIOGRAM KIT	Oct 31, 1991	Unknown	Mega Medical, Inc.
K914141	CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER	Oct 23, 1991	Substantially Equivalent	Cordis Corp.
K911710	HEPARIN COATED THERMODILUTION CATH & ACCESSORIES	Oct 23, 1991	Substantially Equivalent	Sunscope Intl., Inc.
K914007	CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH	Oct 18, 1991	Substantially Equivalent	Cordis Corp.
K911957	ACS RX SUPPORT CATHETER	Sep 06, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K913364	SCIMED 7 FR. & 8 FR.	Aug 30, 1991	Substantially Equivalent	Scimed Life Systems, Inc.
K912076	POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF	Jul 30, 1991	Substantially Equivalent	The R Group
K911605	TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES	Jul 09, 1991	Substantially Equivalent	Target Therapeutics
K911560	ZEPHYR INFUSION CATHETER	Jul 05, 1991	Substantially Equivalent	Target Therapeutics
K911703	CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER	Jun 28, 1991	Substantially Equivalent	Cordis Corp.
K911367	BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH	Jun 10, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910987	7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE	May 29, 1991	Substantially Equivalent	Scimed
K910204	SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)	Apr 24, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910378	PRESSURE MONITORING EXTENSION LINE	Apr 22, 1991	Substantially Equivalent	Professional Medical Services
K910259	SCHNEIDER MAGNARAIL PROBING CATHETER	Apr 18, 1991	Substantially Equivalent	Schneider Intl., Ltd.
K904618	CVIS INSIGHT IMAGING CATHETER	Apr 12, 1991	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K910208	BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS	Apr 01, 1991	Substantially Equivalent	Baxter Healthcare Corp
K903848	DIAGNOSTIC INTRASCULAR CATHETER	Mar 25, 1991	Substantially Equivalent	Applied Vascular Devices, Inc.
K905715	ACS ANGIOSCOPIC CATHETER	Mar 18, 1991	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K905625	CVIS INSIGHT IMAGING CATHETER	Feb 21, 1991	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K905499	SCIMD 7 FR. TRIGUIDE GUIDING CATHETER	Feb 11, 1991	Substantially Equivalent	Scimed Life Systems, Inc.
K905727	USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER	Feb 01, 1991	Substantially Equivalent	C.R. Bard, Inc.
K905297	DIAVENTIONAL CATHETER	Feb 01, 1991	Substantially Equivalent	Cordis Corp.
K904491	TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000	Feb 01, 1991	Substantially Equivalent	Lifestream Int'L, Inc.
K905018	LAB-SITE SAFETY NEEDLE	Jan 16, 1991	Substantially Equivalent	Telos Medical Corp.
K905017	LAB-SITE	Jan 15, 1991	Substantially Equivalent	Telos Medical Corp.
K904959	PSG HEMOSTATIC CONTROL VALVE	Dec 17, 1990	Substantially Equivalent	Peripheral Systems Group
K904788	MEWISSEN CATHETER	Dec 17, 1990	Substantially Equivalent	Boston Scientific Corp
K903199	HOLLOW LUMEN NEEDLE, PART NUMBER: MX920	Dec 17, 1990	Substantially Equivalent	Medex, Inc.
K892671	WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER	Dec 17, 1990	Substantially Equivalent	Wilson Biomedical, Inc.
K902771	ARTERIAL BLOOD SAMPLING KIT	Nov 05, 1990	Substantially Equivalent	Medex, Inc.
K902943	RSI FEMORAL GUIDING CATHETER	Oct 03, 1990	Substantially Equivalent	Retroperfusion Systems, Inc.
K902953	SOFTOUCH GUIDING CATHETER	Sep 28, 1990	Substantially Equivalent	Mallinckrodt Medical
K900460	MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER	Jul 17, 1990	Substantially Equivalent	Novoste Corp.
K901691	CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE	Jul 06, 1990	Substantially Equivalent	Cardiovascular Imaging Systems, Inc.
K895437	SCIMED CORONARY GUIDING CATHETER	Jun 28, 1990	Substantially Equivalent	Scimed Life Systems, Inc.
K895180	USCI 7F LARGE LUMEN GUIDING CATHETER	Apr 23, 1990	Substantially Equivalent	C.R. Bard, Inc.
K894401	BALLOON THERMODILUTION CATHETERS	Apr 19, 1990	Substantially Equivalent	Worldwide Medical
K895542	SONICATH(TM) 5 F	Apr 06, 1990	Substantially Equivalent	Boston Scientific Corp
K896308	CORDIS SHUTTLE CATHETER	Mar 28, 1990	Substantially Equivalent	Cordis Corp.
K897051	MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH	Mar 16, 1990	Substantially Equivalent	Cathlab Corp.
K896741	SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.	Feb 28, 1990	Substantially Equivalent	Schneider Intl., Ltd.
K896690	MODIFIED ANGIOGRAPHIC CATHETER	Jan 24, 1990	Substantially Equivalent	Novoste Corp.
K895146	GUIDING CATHETER	Jan 19, 1990	Substantially Equivalent	Peripheral Systems Group
K885221	MULTILUMEN CENTRAL VENOUS CATHETER	Dec 28, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K893877	BIOCHEM 3100 OXIMETER	Dec 20, 1989	Substantially Equivalent	Biochem International, Inc.
K894168	SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F	Nov 27, 1989	Substantially Equivalent	Baxter Healthcare Corp
K895268	ARROW HANDS-OFF THERMO-PACE	Nov 06, 1989	Substantially Equivalent	Arrow Intl., Inc.
K893830	HEMO-ALERT	Oct 12, 1989	Substantially Equivalent	Koregon Enterprise, Inc.
K891580	INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING	Aug 03, 1989	Substantially Equivalent	Boston Scientific Corp
K890206	E-Z-FLOW ANGIOGRAPHY CATHETERS	May 19, 1989	Substantially Equivalent	E-Z-Em, Inc.
K885348	A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL	May 15, 1989	Substantially Equivalent	Mallinckroot, Inc.
K890420	USCI 7F GUIDE CATHETER	Apr 24, 1989	Substantially Equivalent	C.R. Bard, Inc.
K884354	IMAGER FLUSH CATHETERS	Apr 21, 1989	Substantially Equivalent	Medi-Tech, Inc.
K882658	ANGIOSCOPE FOR PULMONARY ARTERY USE	Jan 26, 1989	Substantially Equivalent	Washington Regulatory Services
K884502	USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER	Jan 18, 1989	Substantially Equivalent	C.R. Bard, Inc.
K884065	CATH LAB MONITORING CATHETER	Jan 12, 1989	Substantially Equivalent	C.R. Bard, Inc.
K883651	MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER	Nov 18, 1988	Substantially Equivalent	Millar Instruments, Inc.
K883051	USCI SOFT-TIP ANGIOGRAPHIC CATHETER	Oct 06, 1988	Substantially Equivalent	C.R. Bard, Inc.
K882655	PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE	Sep 16, 1988	Substantially Equivalent	Procedure Packs, Inc.
K875127	NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS	Aug 09, 1988	Substantially Equivalent	Novoste Corp.
K882796	SLIP-COAT(TM) CATHETERS	Jul 28, 1988	Substantially Equivalent	Cook, Inc.
K875337	HEPARIN COATED LUMINAL PACING CATHETER	May 25, 1988	Substantially Equivalent	Spectramed, Inc.
K880661	FIBEROPTIC CATHETER	May 02, 1988	Substantially Equivalent	Optimed Technologies, Inc.
K875326	MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER	Feb 18, 1988	Substantially Equivalent	Schneider-Shilley (Usa)
K875325	MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK	Feb 18, 1988	Substantially Equivalent	Schneider-Shilley (Usa)
K874815	TARGET THERAPEUTICS STERILE PRODUCTS	Feb 05, 1988	Substantially Equivalent	Target Therapeutics
K874037	ANGIO WASTE FLUIDS DUMP BAG	Jan 29, 1988	Substantially Equivalent	Procedure Products, Inc.
K870700	MICRO-GUIDE	Dec 03, 1987	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K873438	USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER	Nov 27, 1987	Substantially Equivalent	C.R. Bard, Inc.
K873004	GUIDING CATHETER	Sep 15, 1987	Substantially Equivalent	Mallinckrodt Critical Care
K872248	DOUBLE LUMEN CATHETER	Aug 12, 1987	Substantially Equivalent	Cordis Corp.
K871021	GUIDING CATHETERS 9F JL4	Jun 16, 1987	Substantially Equivalent	Devices For Vascular Intervention, Inc.
K870419	IVR-SP CUSTOM ANGIOGRAPHY TRAY	May 11, 1987	Substantially Equivalent	North Coast Medi-Tek
K864943	NUMED BALLOON WEDGE PRESSURE CATHETER	Feb 20, 1987	Substantially Equivalent	NuMED, Inc.
K864940	NUMED BALLOON ANGIOGRAPHIC CATHETERS	Feb 19, 1987	Substantially Equivalent	NuMED, Inc.
K861241	ANGIOTOPO CATHETER	Jan 06, 1987	Substantially Equivalent	Houston Biomedical, Inc.
K852547	CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON	Nov 10, 1986	Substantially Equivalent	Cortronic Corp.
K864141	CORDIS CONTRAST INJECTION LINES	Nov 03, 1986	Substantially Equivalent	Cordis Corp.
K863137	TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER	Oct 10, 1986	Substantially Equivalent	Terumo Medical Corp.
K863337	CORDIPAK CARDIAC CATHETERIZATION PACK	Sep 29, 1986	Substantially Equivalent	Angi-Pak Corp.
K862673	MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER	Sep 11, 1986	Substantially Equivalent	Medtronic Vascular
K862466	SCHNEIDER-SHILEY FLUSHING CATHETER	Aug 29, 1986	Substantially Equivalent	Shiley, Inc.
K862464	SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR	Aug 28, 1986	Substantially Equivalent	Shiley, Inc.
K862244	MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS	Aug 25, 1986	Substantially Equivalent	Cordis Corp.
K862465	SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK	Aug 11, 1986	Substantially Equivalent	Shiley, Inc.
K862030	POLY-TECH ANGIOGRAPHY CATHETER	Aug 08, 1986	Substantially Equivalent	Poly-Tech Medical Device Research & Development
K854910	ANGIOFLOW	Jul 17, 1986	Substantially Equivalent	Angiomed U.S., Inc.
K861236	ACS CORONARY GUIDING CATHETER	Jul 10, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K860867	DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS	Jul 02, 1986	Substantially Equivalent	Medical Components, Inc.
K862006	STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH	Jun 27, 1986	Substantially Equivalent	Cordis Corp.
K861483	ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)	May 15, 1986	Substantially Equivalent	Mallinckrodt Critical Care
K860805	PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337	May 08, 1986	Substantially Equivalent	Gould, Inc.
K860429	MEADOX SURGIMED GUIDE CATHETER	Apr 23, 1986	Substantially Equivalent	Meadox Surgimed, Inc.
K860580	ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP	Mar 31, 1986	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K854576	MODIFIED CORDIS PTCA GUIDING CATHETERS	Feb 26, 1986	Substantially Equivalent	Cordis Corp.
K855103	CIRIBART GYUDUBG CATGETER	Feb 18, 1986	Substantially Equivalent	Mansfield Scientific, Inc.
K854018	ANGIOGRAPHY CATHETERS	Jan 16, 1986	Substantially Equivalent	Micor, Inc.
K853182	DIAGNOSTIC INTRAVASCULAR CATHETERS	Jan 15, 1986	Substantially Equivalent	Mallinckrodt Critical Care
K852197	LAP-CATH	Nov 06, 1985	Substantially Equivalent	Research Medical, Inc.
K852456	FAP-CATH	Nov 01, 1985	Substantially Equivalent	Research Medical, Inc.
K852872	ANGIOMEDICS SOFTIP CATHETER	Oct 11, 1985	Substantially Equivalent	Angiomedics, Inc.
K844854	OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT	May 21, 1985	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K851088	UMI ANGIOGRAPHIC CATHETER	May 16, 1985	Substantially Equivalent	Universal Medical Instrument Corp.
K844800	OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS	May 16, 1985	Substantially Equivalent	Vas-Cath of Canada , Ltd.
K850271	ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR	Apr 03, 1985	Substantially Equivalent	Angiomedics, Inc.
K844555	PATHFINDER CARDIOVASCULAR CATHETER	Mar 27, 1985	Substantially Equivalent	Argon Medical Corp.
K850341	CARDIOVASCULAR SET UP	Feb 25, 1985	Substantially Equivalent	Marwood Medical, Inc.
K844598	LARIAT CATHETER	Feb 01, 1985	Substantially Equivalent	Mallinckrodt Critical Care
K844161	PTCA GUIDING CATHER	Jan 02, 1985	Substantially Equivalent	Cordis Corp.
K843726	NAMIC ADB ANGIOGRAPHIC DUMP BAG	Oct 18, 1984	Substantially Equivalent	North American Instrument Corp.
K842799	PERCUTANEOUS ANGIOSCOPE DELIVERY CATH	Aug 10, 1984	Substantially Equivalent	American Edwards Laboratories
K842798	INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH	Aug 10, 1984	Substantially Equivalent	American Edwards Laboratories
K842195	ADVANCED CARDIOVASCULAR-CORONARY GUID	Jul 13, 1984	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K840763	SILVERTORQUE CARDIAC CATHETERS	Jun 13, 1984	Substantially Equivalent	Surgimed Corp.
K841615	ELECATH HEPARIN-COATED CATHETERS	Jun 05, 1984	Substantially Equivalent	Electro-Catheter Corp.
K833554	MATERIAL ADDITION LEXAN & K-RESIN	Mar 12, 1984	Substantially Equivalent	Procedure Products, Inc.
K834459	DIAGNOSTIC RADIOLOGY CATHETERS	Feb 04, 1984	Substantially Equivalent	American Edwards Laboratories
K834275	SOFTIP CATHETER	Feb 04, 1984	Substantially Equivalent	Angiomedics, Inc.
K832386	PERCLUDER DL OCCLUDING BALLOON	Oct 19, 1983	Substantially Equivalent	Datascope Corp.
K831337	COMPRESSAR DISPOSABLE DISC	Jul 19, 1983	Substantially Equivalent	Instromedix, Inc.
K831562	SONTEK INFUSION CATHETER	Jun 30, 1983	Substantially Equivalent	Sontek Corp.
K831509	ANGIOGRAPHY KIT W/ADDIT. COMPONENTS	Jun 08, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K831171	DIGICATH	May 25, 1983	Substantially Equivalent	Argon Medical Corp.
K831189	ANGIOGRAPHIC NEEDLE	May 09, 1983	Substantially Equivalent	Medrad, Inc.
K830788	CENTRAL VEIN CATHERIZATION KIT-14-690-	Apr 30, 1983	Substantially Equivalent	Norton Performance Plastics Corp.
K830415	DIAGNOSTIC INTRAVASCULAR CATHETER	Apr 28, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K830734	FORGARTY BALLOON CALIBRATOR	Apr 12, 1983	Substantially Equivalent	American Edwards Laboratories
K830025	DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-	Mar 31, 1983	Substantially Equivalent	Medrad/Technology For People
K830637	VERTEX DIGITAL SUBSTRATION KIT	Mar 24, 1983	Substantially Equivalent	Professional Medical Services
K823754	SAHOTA-KAPLAN HEMOSTAT	Mar 24, 1983	Substantially Equivalent	Erickson Industries, Inc.
K830576	LYMPHANGIOGRAPHY SET	Mar 17, 1983	Substantially Equivalent	Vertex Medical Corp.
K830523	CATHETER CONNECTION W/INTEGRAL INJECTATE	Mar 16, 1983	Substantially Equivalent	Gould, Inc.
K823357	VARIOUS CARDIOVASCULAR PRODUCTS	Mar 11, 1983	Substantially Equivalent	C.R. Bard, Inc.
K830420	POLYETHYLENE MONITORING CONNECTORS	Feb 28, 1983	Substantially Equivalent	Vertex Medical Corp.
K823758	CENTRAL VEIN CATHERIZATION KIT	Feb 23, 1983	Substantially Equivalent	Access Devices, Inc.
K830237	TRANSLUCENT POLY. CATH. CONNECTOR AND	Feb 18, 1983	Substantially Equivalent	Vertex Medical Corp.
K823064	INTRACATH-DA INTRAVENOUS CATH. PLACEMENT	Jan 27, 1983	Substantially Equivalent	Parke-Davis Co.
K830022	S.M.P. CONTRAST MEDIA SET	Jan 21, 1983	Substantially Equivalent	Omega Technologies, Inc.
K823243	SIDEARM Y-ADAPTOR	Jan 21, 1983	Substantially Equivalent	American Edwards Laboratories
K823065	INTRA CATH-DSA INTRAVENOUS CATH PLACE.	Dec 15, 1982	Substantially Equivalent	Parke-Davis Co.
K822862	BRACHIAL CORONARY GUIDING CATHETER	Oct 18, 1982	Substantially Equivalent	Advanced Cardiovascular Systems, Inc.
K822640	CORONARY INFUSION KIT	Sep 28, 1982	Substantially Equivalent	Mallinckrodt Critical Care
K822598	TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS	Sep 28, 1982	Substantially Equivalent	Vertex Medical Corp.
K822594	POLYETHYLENE CARDIOVASCULAR CATHETER	Sep 28, 1982	Substantially Equivalent	Vertex Medical Corp.
K822596	VERTEX PERCUTANEOUS PUNCTURE NEEDLE	Sep 21, 1982	Substantially Equivalent	Vertex Medical Corp.
K822290	STERILE PROTECTIVE SLEEVE W/TOUGH-BORST	Aug 31, 1982	Substantially Equivalent	Universal Medical Instrument Corp.
K822243	GUIDING CATHETER	Aug 24, 1982	Substantially Equivalent	Interventional Medical, Inc.
K822100	HIGH PRESSURE CONTRAST INJECTION LINE	Aug 24, 1982	Substantially Equivalent	Namic
K822033	BERMAN ANGIOGRAPHIC BALLOON CATHETER	Aug 24, 1982	Substantially Equivalent	Ziehm International, Inc.
K821816	ANGIOGRAPHIC CATHETER	Aug 24, 1982	Substantially Equivalent	Medi-Tech, Inc.
K821976	ANGIOGRAPHY KIT	Jul 20, 1982	Substantially Equivalent	Mallinckrodt Critical Care
K820001	CORONARY INFUSION KIT	Jan 29, 1982	Substantially Equivalent	Mallinckrodt Critical Care
K813577	PRESSURE INDICATOR-REGULATOR	Jan 29, 1982	Substantially Equivalent	Advanced Catheter Systems
K813624	ADVANCED CATHETER SYSTEMS CORONARY GUID	Jan 22, 1982	Substantially Equivalent	Advanced Catheter Systems
K813623	SIMPSON-ROBERT CORONARY GUIDING CATHET	Jan 22, 1982	Substantially Equivalent	Advanced Catheter Systems
K813622	INDEFLATOR	Jan 22, 1982	Substantially Equivalent	Advanced Catheter Systems
K813142	LEADER-CATH	Nov 27, 1981	Substantially Equivalent	Exco, Inc.
K813140	VYGON EXTENSION TUBES & CONNECTORS	Nov 27, 1981	Substantially Equivalent	Exco, Inc.
K812999	PET POLYETHYLENE TORQUE CATHETER	Nov 16, 1981	Substantially Equivalent	Universal Medical Instrument Corp.
K810508	SONTEK ANGIOGRAPHIC CATHETER	Apr 17, 1981	Substantially Equivalent	Sontek Corp.
K803270	GANZ CORONARY REPERFUSION CATHETER	Mar 27, 1981	Substantially Equivalent	American Edwards Laboratories
K810360	BAIM TM CORONARY SINUS FLOW THERMAL	Mar 11, 1981	Substantially Equivalent	Electro-Catheter Corp.
K810412	USCI CARDIOVASCULAR CATHETER	Mar 05, 1981	Substantially Equivalent	C.R. Bard, Inc.
K802945	PRESSURE MONITORING SET	Dec 19, 1980	Substantially Equivalent	Norton Performance Plastics Corp.
K802629	STERI-SLEEVE	Oct 31, 1980	Substantially Equivalent	Cordis Corp.
K801322	MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS	Jun 30, 1980	Substantially Equivalent	Graphic Controls Corp.
K801321	PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE	Jun 30, 1980	Substantially Equivalent	Graphic Controls Corp.
K800622	EXTENSION LINE	Apr 29, 1980	Substantially Equivalent	Norton Performance Plastics Corp.
K800618	SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET	Apr 24, 1980	Substantially Equivalent	Norton Performance Plastics Corp.
K800741	CENTRAL VEIN CATHETERIZATION KIT	Apr 16, 1980	Substantially Equivalent	Medical Components, Inc.
K800703	MODIFIED CATHETER PACKAGE	Apr 08, 1980	Substantially Equivalent	Hancock Laboratories, Inc.
K800461	CENTRAL VENOUS PRESSURE CATHETER	Mar 12, 1980	Substantially Equivalent	Medical Components, Inc.
K800171	DIAGNOSTIC INTRAVASCULAR CATHETER	Feb 01, 1980	Substantially Equivalent	Flomed, Inc.
K791915	WHITE SEALING CAP	Dec 19, 1979	Substantially Equivalent	Quinton, Inc.
K790107	CATHETER TUBING MODIFICATION	Feb 01, 1979	Substantially Equivalent	Jelco Laboratories
K790082	ARTERIAL EXTENSION SET	Jan 25, 1979	Substantially Equivalent	Namic
K781819	POST EXTRA SYSTOLIC POTENTIATOR	Jan 15, 1979	Substantially Equivalent	Medrad, Inc.
K782082	CATHETER, DIGITAL POSITRAL II	Dec 20, 1978	Substantially Equivalent	C.R. Bard, Inc.
K781558	PRESSURE MONITORING INJECTION LINES	Oct 10, 1978	Substantially Equivalent	Cobe Laboratories, Inc.
K780529	MYOCATH KIT	May 09, 1978	Substantially Equivalent	Sorensen Research
K772175	CATHETER SYSTEM, COPE/EISENBERG	Nov 28, 1977	Substantially Equivalent	Victory Engineering Corp.
K771810	PRESSURE TUBING	Nov 17, 1977	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K770868	CATHETER, POLYURETHANE, W/STYLET	Jun 27, 1977	Substantially Equivalent	Abbott Laboratories
K770290	MONITORING KIT, CENTRAL VENOUS PRESSURE	Mar 15, 1977	Substantially Equivalent	Argon Medical Corp.
K770462	PUNCTURE KIT, INTERNAL JUGULAR	Mar 14, 1977	Substantially Equivalent	Arrow Intl., Inc.
K760388	CATHETER, VEIN (VENOFIX)	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments
K760387	CATHETER, CAVA (CAVAFIX)	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments
K760386	CENTRAL VEINOUS PRESSURE SETS	Nov 02, 1976	Substantially Equivalent	B. Braun Instruments
K760402	SYRINGE SET, 3-WAY THERMODILUTIN	Aug 23, 1976	Substantially Equivalent	Omp Laboratories, Inc.