Product Code: DSY FDA class 2 21 CFR 870.3450

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cardiovascular

The Vascular Graft Prosthesis of 6mm and Greater Diameter is an implantable cardiovascular device used to replace or bypass diseased or damaged large blood vessels, maintaining blood flow through the reconstructed vascular segment. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSY and it is regulated under 21 CFR 870.3450 within the Cardiovascular medical specialty. This device is flagged as an implant.

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510(k)s

188

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DSY
Device Class: FDA class 2
Regulation Number: 870.3450
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 188 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252445	Fusion Bioline Vascular Graft	Apr 27, 2026	Substantially Equivalent	Maquet Cardiovascular, LLC
K252277	Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)	Oct 20, 2025	Substantially Equivalent	Vascular Flow Technologies Limited
K241550	Gelweave Vascular Prostheses	Feb 27, 2025	Substantially Equivalent	Vascutek, Ltd.
K241070	Gelsoft Plus Vascular Prostheses	Nov 15, 2024	Substantially Equivalent	Vascutek, Ltd.
K231972	Advanta VXT Vascular Graft, Flixene Vascular Graft	Mar 28, 2024	Substantially Equivalent	Atrium Medical Corporation
K240083	GORE® PROPATEN® Vascular Graft	Mar 01, 2024	Substantially Equivalent	W. L. Gore & Associates, Inc.
K233783	exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts	Jan 17, 2024	Substantially Equivalent	Peca Labs, Inc.
K232312	GORE® PROPATEN® Vascular Graft	Jan 09, 2024	Substantially Equivalent	W. L. Gore & Associates, Inc.
K233551	GORE® ACUSEAL Vascular Graft	Dec 19, 2023	Substantially Equivalent	W. L. Gore & Associates, Inc.
K231505	GORE® ACUSEAL Vascular Graft	Jun 23, 2023	Substantially Equivalent	W. L. Gore & Associates, Inc.
K213845	HeRO Graft	Aug 15, 2022	Substantially Equivalent	Merit Medical Systems, Inc.
K221628	exGraft, exGraft Carbon	Aug 04, 2022	Substantially Equivalent	Peca Labs
K203724	HeRO Graft, HeRO Adapter	May 25, 2021	Substantially Equivalent	Merit Medical Systems, Inc.
K202703	Vascutek Gelsoft Plus ERS Vascular Graft	Apr 06, 2021	Substantially Equivalent	Vascutek, Ltd.
K202471	exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft	Dec 11, 2020	Substantially Equivalent	Peca Labs
K183613	exGraft, exGraft Carbon	Apr 22, 2019	Substantially Equivalent	Peca Labs
K180957	exGraft, exGraft Carbon ePTFE Vascular Grafts	Aug 21, 2018	Substantially Equivalent	Peca Labs
K172637	HeRO Graft	Nov 30, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K162803	Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts	Jul 14, 2017	Substantially Equivalent	Vascutek, Ltd.
K162794	Gelweave Vascular Grafts	Jun 30, 2017	Substantially Equivalent	Vascutek, Ltd.
K153523	FUSION Vascular Graft	Feb 16, 2016	Substantially Equivalent	Maquet Cardiovascular, LLC
K150389	Spiral Flow Peripheral Vascular Graft	May 06, 2015	Substantially Equivalent	Vascular Flow Technologies, Ltd.
K142062	SPIRAL FLOW PERIPHERAL VASCULAR GRAFT	Nov 20, 2014	Substantially Equivalent	Vascular Flow Technologies, Ltd.
K141124	SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT	May 30, 2014	Substantially Equivalent	Vascular Flow Technologies, Ltd.
K131778	FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT	Nov 14, 2013	Substantially Equivalent	Maquet Cardiovascular, LLC
K130215	GORE ACUSEAL VASCULAR GRAFT	Apr 09, 2013	Substantially Equivalent	W. L. Gore & Associates, Inc.
K130142	FLIXENE IFG VASCULAR GRAFT	Mar 15, 2013	Substantially Equivalent	Atrium Medical Corporation
K124039	HERO GRAFT	Mar 07, 2013	Substantially Equivalent	Hemoshpere, Inc., A Cryolife Company
K130016	LIFESPAN EPTFE VASCULAR GRAFT	Feb 05, 2013	Substantially Equivalent	LeMaitre Vascular, Inc.
K122138	ATRIUM FLIXENE IFG VASCULAR GRAFT	Aug 17, 2012	Substantially Equivalent	Atrium Medical Corp.
K121532	HERO GRAFT	Jun 22, 2012	Substantially Equivalent	Hemosphere, Inc.
K120006	HERO GRAFT	Feb 02, 2012	Substantially Equivalent	Hemosphere, Inc.
K113101	EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL	Jan 17, 2012	Substantially Equivalent	Boston Scientific Corporation
K103347	CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES	Feb 02, 2011	Substantially Equivalent	Intervascular Sas
K102596	ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT	Oct 05, 2010	Substantially Equivalent	Atrium Medical Corp.
K094044	SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT	Mar 23, 2010	Substantially Equivalent	Tayside Flow Technologies Limited
K093934	GORE HYBRID VASCULAR GRAFT	Mar 17, 2010	Substantially Equivalent	W.L. Gore & Associates
K093817	GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS	Jan 07, 2010	Substantially Equivalent	Vascutek, Ltd.
K092863	MAXIFLO, TAPERFLO	Oct 08, 2009	Substantially Equivalent	Vascutek, Ltd.
K091778	VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS	Aug 31, 2009	Substantially Equivalent	Vascutek, Ltd.
K091491	HERO VASCULAR ACCESS DEVICE	Jul 31, 2009	Substantially Equivalent	Hemosphere, Inc.
K090987	VASCUTEK BRANCHED GELWEAVE	Jun 19, 2009	Substantially Equivalent	Vascutek, Ltd.
K083169	EPTFE SLFTM SPIRAL VASCULAR GRAFT	Mar 30, 2009	Substantially Equivalent	Tayside Flow Technologies Limited
K071778	HERO VASCULAR ACCESS DEVICE	Jan 30, 2008	Substantially Equivalent	Graftcath, Inc.
K071923	PTFE FLIXENE GRADUATED WALL GRAFT	Aug 14, 2007	Substantially Equivalent	Atrium Medical Corp.
K062161	GORE PROPATEN VASCULAR GRAFT	Nov 09, 2006	Substantially Equivalent	W. L. Gore & Associates, Inc.
K061626	VASORING* VRC VASCULAR RING CONNECTOR	Oct 05, 2006	Substantially Equivalent	Sunwei Tech Co. , Ltd.
K060741	SWIRLGRAFT VASCULAR ACCESS GRAFT	Apr 05, 2006	Substantially Equivalent	Veryan Medical Limited
K060124	ATRIUM FLIXENE GRAFT	Mar 30, 2006	Substantially Equivalent	Atrium Medical Corp.
K060142	VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS	Feb 07, 2006	Substantially Equivalent	Vascutek, Ltd.
K052964	EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN	Jan 06, 2006	Substantially Equivalent	Boston Scientific Corp
K051312	SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS	Nov 04, 2005	Substantially Equivalent	Veryan Medical Limited
K051332	ADVANTA T-GRAFT	Sep 29, 2005	Substantially Equivalent	Atrium Medical Corp.
K052282	VENAFLO II VASCULAR GRAFT	Sep 20, 2005	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K050049	DYNAFLO BYPASS GRAFT	Jan 31, 2005	Substantially Equivalent	Bard Peripheral Vascular, Inc.
K043552	VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES	Jan 05, 2005	Substantially Equivalent	Vascutek, Ltd.
K041528	MODIFICATION TO EPTFE GRAFT	Sep 14, 2004	Substantially Equivalent	Vascutek, Ltd.
K040829	GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR	May 20, 2004	Substantially Equivalent	Vascutek, Ltd.
K034010	GELSOFT PLUS ERS	Feb 19, 2004	Substantially Equivalent	Vascutek, Ltd.
K032900	LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS	Dec 04, 2003	Substantially Equivalent	Edwards Lifesciences, LLC
K030999	EPTFE VASCULAR PROSTHESIS; SEALPTFE	Apr 09, 2003	Substantially Equivalent	Vascutek, Ltd.
K021547	FLOWLINE BIOPORE EPTFE VASCULAR GRAFT	Jan 24, 2003	Substantially Equivalent	Jotec GmbH
K022242	INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER	Aug 14, 2002	Substantially Equivalent	Intervascular
K013022	SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS	Jun 13, 2002	Substantially Equivalent	Sulzer Carbomedics, Inc.
K020767	ADVANTA SST BIFURCATED GRAFT	Apr 03, 2002	Substantially Equivalent	Atrium Medical Corp.
K013651	INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS	Feb 27, 2002	Substantially Equivalent	Intervascular
K013577	ULTRAMAX WOVEN VELOUR VASCULAR GRAFT	Jan 25, 2002	Substantially Equivalent	Atrium Medical Corp.
K013250	GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT	Oct 26, 2001	Substantially Equivalent	W. L. Gore & Associates, Inc.
K012952	HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT	Oct 02, 2001	Substantially Equivalent	Boston Scientific/Medi-Tech
K010517	ADVANTA SST GRAFT (<6MM)	May 18, 2001	Substantially Equivalent	Atrium Medical Corp.
K010516	ADVANTA SST GRAFT (>_6MM)	May 18, 2001	Substantially Equivalent	Atrium Medical Corp.
K004011	IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS	Mar 27, 2001	Substantially Equivalent	Impra, Inc.
K002007	SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS	Jan 25, 2001	Substantially Equivalent	Sulzer Carbomedics, Inc.
K990800	INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS	Jan 08, 2001	Substantially Equivalent	Intervascular, Inc.
K001927	VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME	Dec 18, 2000	Substantially Equivalent	Thoratec Laboratories Corp.
K000499	ADVANTA SUPER SOFT GRAFT	Mar 01, 2000	Substantially Equivalent	Atrium Medical Corp.
K993667	SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS	Jan 28, 2000	Substantially Equivalent	Sulzermedica
K990503	SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS	Dec 09, 1999	Substantially Equivalent	Sulzermedica
K992832	SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS	Nov 19, 1999	Substantially Equivalent	Sulzermedica
K992960	ADVANTA GRAFT (>6MM)	Oct 01, 1999	Substantially Equivalent	Atrium Medical Corp.
K992443	ADVANTA GRAFT	Aug 20, 1999	Substantially Equivalent	Atrium Medical Corp.
K991602	EPTFE RINGED GORE-TEX VASCULAR GRAFT	Jul 09, 1999	Substantially Equivalent	W. L. Gore & Associates, Inc.
K991813	UNI-GRAFT K DV VASCULAR GRAFT	Jun 01, 1999	Substantially Equivalent	Atrium Medical Corp.
K991027	BI-DIRECTIONAL TUNNELER	Apr 22, 1999	Substantially Equivalent	Impra, Inc.
K984294	MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES	Feb 22, 1999	Substantially Equivalent	Intervascular, Inc.
K984182	PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452	Feb 01, 1999	Substantially Equivalent	Possis Medical, Inc.
K983861	DISTAFLO BYPASS GRAFT	Nov 24, 1998	Substantially Equivalent	Impra, Inc.
K983819	INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN	Nov 24, 1998	Substantially Equivalent	Intervascular, Inc.
K983064	IMPRA HIGH POROSITY GRAFT	Nov 19, 1998	Substantially Equivalent	Impra, Inc.
K981079	VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT	May 07, 1998	Substantially Equivalent	Impra, Inc.
K963790	UNI-GRAFT K DV	Jul 21, 1997	Substantially Equivalent	Atrium Medical Corp.
K970843	INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES	Jun 05, 1997	Substantially Equivalent - Subject to Tracking Reg.	Intervascular, Inc.
K964625	HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES	May 05, 1997	Substantially Equivalent - Subject to Tracking Reg.	Intervascular, Inc.
K971192	IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT	Apr 15, 1997	Substantially Equivalent - Subject to Tracking Reg.	Impra, Inc.
K962433	MEADOX EXXCEL EPTFE VASCULAR GRAFT	Mar 17, 1997	Substantially Equivalent - Subject to Tracking Reg.	Meadox Medicals, Div. Boston Scientific Corp.
K964959	VASCUTEK TWILLWEAVE VASCULAR GRAFT	Mar 10, 1997	Substantially Equivalent - Subject to Tracking Reg.	Vascutek, Ltd.
K964665	VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)	Feb 19, 1997	Substantially Equivalent - Subject to Tracking Reg.	Carbomedics, Inc.
K961847	HEMASHIELD VANTAGE (VASCULAR GRAFT	Jan 22, 1997	Substantially Equivalent - Subject to Tracking Reg.	Meadox Medicals, Div. Boston Scientific Corp.
K964197	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	Jan 02, 1997	Substantially Equivalent	Impra, Inc.
K962639	IMPRA CARBOFLO EPTFE VASCULAR GRAFT	Oct 03, 1996	Unknown	Impra, Inc.
K961134	BARD GRAFT SIZER	Jun 19, 1996	Substantially Equivalent - Subject to Tracking Reg.	C.R. Bard, Inc.
K955460	MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT	May 30, 1996	Substantially Equivalent - Subject to Tracking Reg.	Meadox Medicals, Div. Boston Scientific Corp.
K960706	VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT	Apr 25, 1996	Unknown	Carbomedics, Inc.
K955532	DIASTAT VASCULAR ACCESS GRAFT	Mar 11, 1996	Substantially Equivalent - Subject to Tracking Reg.	W. L. Gore & Associates, Inc.
K955588	VASCUTEK GRAFT SIZER SET	Mar 07, 1996	Substantially Equivalent - Subject to Tracking Reg.	Carbomedics, Inc.
K955230	VASCUTEK GELSOFT PLUS VASCULAR GRAFT	Feb 09, 1996	Substantially Equivalent - Subject to Tracking Reg.	Vascutek, Ltd.
K952293	VASCUTEK GELWEAVE VASCULAR GRAFT	Dec 19, 1995	Substantially Equivalent - Subject to Tracking Reg.	Vascutek, Ltd.
K954582	BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)	Dec 07, 1995	Substantially Equivalent - Subject to Tracking Reg.	C.R. Bard, Inc.
K953288	DIASTAT VASCULAR ACCESS GRAFT	Oct 06, 1995	Substantially Equivalent - Subject to Tracking Reg.	W. L. Gore & Associates, Inc.
K944858	BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS	Jan 05, 1995	Substantially Equivalent - Subject to Tracking Reg.	Baxter Edwards
K941981	AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED	Jul 20, 1994	Substantially Equivalent - Subject to Tracking & PMS	W. L. Gore & Associates, Inc.
K940816	BARD(R) EXPANDED PTFE VASCULAR GRAFT	Jun 02, 1994	Substantially Equivalent - Subject to Tracking Reg.	C.R. Bard, Inc.
K933987	AOR-TEX VASCULAR GRAFT	May 17, 1994	Substantially Equivalent - Subject to Tracking Reg.	W. L. Gore & Associates, Inc.
K940062	DIASTAT VASCULAR ACCESS GRAFT	May 02, 1994	Substantially Equivalent - Subject to Tracking & PMS	W. L. Gore & Associates, Inc.
K933590	BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT	Jan 26, 1994	Substantially Equivalent	Baxter Healthcare Corp
K933943	FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS	Dec 08, 1993	Substantially Equivalent	W. L. Gore & Associates, Inc.
K933204	BARD PTFE VASCULAR GRAFT	Oct 27, 1993	Substantially Equivalent	C.R. Bard, Inc.
K925123	ATRIUM'S HYBRID PTFE	May 27, 1993	Unknown	Atrium Medical Corp.
K922905	FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT	Nov 24, 1992	Unknown	W. L. Gore & Associates, Inc.
K922025	ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF	Sep 22, 1992	Substantially Equivalent	Pioneering Technologies, Inc.
K914116	PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION	Nov 27, 1991	Substantially Equivalent	Medtronic Vascular
K914447	GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE	Nov 05, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K913143	OCHSNER ULP BIFURCATION VASCULAR PROTHESIS	Oct 23, 1991	Substantially Equivalent	Intervascular, Inc.
K912911	LOW POROSITY (LP) VASCULAR PROSTHESIS	Sep 23, 1991	Substantially Equivalent	Intervascular, Inc.
K905269	OCHSNER 500 VASCULAR PROSTHESIS	Apr 02, 1991	Substantially Equivalent	Intervascular, Inc.
K910866	VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS	Apr 01, 1991	Substantially Equivalent	Vascutek, Ltd.
K910865	TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS	Apr 01, 1991	Substantially Equivalent	Vascutek, Ltd.
K910864	EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS	Apr 01, 1991	Substantially Equivalent	Vascutek, Ltd.
K910863	EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS	Apr 01, 1991	Substantially Equivalent	Vascutek, Ltd.
K905067	PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT	Mar 18, 1991	Substantially Equivalent	Pioneering Technologies, Inc.
K905270	OCHSNER 50 VASCULAR PROSTHESIS	Feb 15, 1991	Substantially Equivalent	Intervascular, Inc.
K904282	BIFURCATED GORE TEX STRETCH VASCULAR GRAFT	Jan 16, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K903931	GORE-TEX(R) STRETCH VASCULAR GRAFT	Dec 06, 1990	Substantially Equivalent	W. L. Gore & Associates, Inc.
K903964	OCHSNER 50 BIFURCATION	Dec 03, 1990	Substantially Equivalent	Intervascular, Inc.
K901641	AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT	Sep 05, 1990	Substantially Equivalent	W. L. Gore & Associates, Inc.
K901682	PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS	Jul 03, 1990	Substantially Equivalent	Pioneering Technologies, Inc.
K896964	PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.	Jun 21, 1990	Substantially Equivalent	Medtronic Vascular
K890182	PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV	Feb 28, 1990	Substantially Equivalent	Aesculap Instruments Corp.
K894732	VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)	Oct 12, 1989	Substantially Equivalent	Medtronic Vascular
K890597	EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS	Sep 26, 1989	Substantially Equivalent	D-R Medical Systems, Inc.
K893459	PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)	Sep 20, 1989	Substantially Equivalent	Medtronic Vascular
K884083	TORAY VASCULAR PROSTHESIS	Jan 12, 1989	Substantially Equivalent	Toray Industries (America), Inc.
K882289	ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.	Dec 12, 1988	Substantially Equivalent	Aries Medical, Inc.
K882314	CORONARY VEIN GRAFT MARKER	Aug 04, 1988	Substantially Equivalent	Med-Edge, Inc.
K880041	VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT	Jun 10, 1988	Substantially Equivalent	D-R Medical Systems, Inc.
K880040	VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT	Jun 09, 1988	Substantially Equivalent	D-R Medical Systems, Inc.
K881283	MEADOX INTRA-AORTIC GRAFT	May 26, 1988	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K880167	GORE-TEX VASCULAR GRAFT	May 18, 1988	Substantially Equivalent	W. L. Gore & Associates, Inc.
K870884	RADIALLY-SUPPORTED VASCULAR PROSTHESES	Feb 05, 1988	Substantially Equivalent	Intervascular, Inc.
K871110	CORONARY ARTERY BYPASS GRAFT (CABG) MARKER	Aug 27, 1987	Substantially Equivalent	Edward Weck, Inc.
K862697	AVTECH LWP(LOW POROSITY) MWP(MEDIUM POROSITY)	Dec 05, 1986	Substantially Equivalent	Advanced Vascular Technologies, Inc.
K861808	VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN	Sep 15, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K862739	INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES	Aug 21, 1986	Substantially Equivalent	Intervascular, Inc.
K854845	INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR	Aug 18, 1986	Substantially Equivalent	Intervascular, Inc.
K841596	MEADOS INTRAORTIC GRAFT	May 08, 1986	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K854431	MEADOX MEDICALS INC. GRAFT SIZER	May 07, 1986	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K853101	VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES	Feb 24, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K853725	ATRIUM PLASMA TFE SYNTHETIC ARTERY	Dec 09, 1985	Substantially Equivalent	Atrium Medical Corp.
K831822	TETRAFLEX INTEGRALLY SUPPORTED PTFE	Oct 16, 1984	Substantially Equivalent	Shiley, Inc.
K833716	LP200 & HP800 SERIES VASCULAR PROSTH	Jan 10, 1984	Substantially Equivalent	Intervascular, Inc.
K830016	VASCUTEK VASCULAR PROTHESIS VP1200K/50K	Dec 21, 1983	Substantially Equivalent	Pacesetter Systems
K831880	IONESCU-SHILEY LOW POROSITY AORTIC GRAFT	Oct 19, 1983	Substantially Equivalent	Shiley, Inc.
K831865	IONESCU-SHILEY LOW POROSITY COMPOSITE	Oct 19, 1983	Substantially Equivalent	Shiley, Inc.
K832806	CORONARY ANASTOMOSIS MARKING SYSTEM	Sep 29, 1983	Substantially Equivalent	Biotrac Laboratories
K830543	VASCULAR GRAFT PROSTHESIS EXPANDED MICR	Jul 19, 1983	Substantially Equivalent	Impra, Inc.
K822633	MICROVEL DOUBLE VELOUR SUPPORTED 100	Jul 12, 1983	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K821716	BARD PTFE VASCULAR PROSTHESIS	Aug 31, 1982	Substantially Equivalent	C.R. Bard, Inc.
K820696	MEADOX WOVEN DOUBLE VELOUR	Jul 09, 1982	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K820600	HANCOCK VASCULAR GRAFT	Jul 08, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K821158	FED RINGED-TEX VASCULAR GRAFT	May 18, 1982	Substantially Equivalent	W. L. Gore & Associates, Inc.
K812248	COOLEY 2 VASCULAR PROSTHESIS STRAIGHT	Nov 24, 1981	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K811441	MANUFACTURING PROCESS CHANGE	Sep 16, 1981	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K811510	GORE-TEX VASULAR GRAFT	Aug 20, 1981	Substantially Equivalent	W. L. Gore & Associates, Inc.
K810845	DOUBLE VELOUR GRAFTS	May 08, 1981	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K810376	MEADOX SZILAGYI GRAFT	Mar 05, 1981	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K803000	IONESCU-SHILEY AORTIC GRAFT VALVE	Feb 02, 1981	Substantially Equivalent	Shiley, Inc.
K802095	GORE-TEX VASCULAR GRAFT	Oct 10, 1980	Substantially Equivalent	W. L. Gore & Associates, Inc.
K801621	VASCULAR GRAFT PROSTH. OF EXP. MICRO.	Sep 09, 1980	Substantially Equivalent	Impra, Inc.
K801156	USCI INTRALUMINAL GRAFT W/DACRON TIE	May 23, 1980	Substantially Equivalent	C.R. Bard, Inc.
K800149	USCI SAUVAGE EXS VASCULAR PROSTHESIS	Feb 28, 1980	Substantially Equivalent	C.R. Bard, Inc.
K791828	BJORK-SHILEY PULMONIC GRAFT VALVE	Sep 27, 1979	Substantially Equivalent	Shiley, Inc.
K771819	CABG RINGS	Oct 21, 1977	Substantially Equivalent	A&A Ent.
K770236	SAUVAGE FILAMENTOUS PROSTHESES	Feb 25, 1977	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.
K770235	DEBAKEY VASCULOUR-D PROSTHESES	Feb 24, 1977	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.
K760130	PROSTHESIS, VASCULAR BIFURCATED	Jul 20, 1976	Substantially Equivalent	Usci, Div. C.R. Bard, Inc.
K760092	GRAFT, COOLEY WOVEN VASCULAR, STERILE	Jul 20, 1976	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K760091	GRAFT, MICROVEL GUIDELINE, STERILE	Jul 20, 1976	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K760090	GRAFT, COOLEY GUIDELINE, STERILE	Jul 20, 1976	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.