Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA product code DSY · 185 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3450
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2026-04-27

DSY 2026-04-27

Fusion Bioline Vascular Graft

Applicant Maquet Cardiovascular, LLC

K number K252445

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DSY 2025-10-20

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)

Applicant Vascular Flow Technologies Limited

K number K252277

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DSY 2025-02-27

Gelweave™ Vascular Prostheses

Applicant Vascutek, Ltd.

K number K241550

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DSY 2024-11-15

Gelsoft™ Plus Vascular Prostheses

Applicant Vascutek, Ltd.

K number K241070

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DSY 2024-03-28

Advanta VXT Vascular Graft, Flixene Vascular Graft

Applicant Atrium Medical Corporation

K number K231972

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DSY 2024-03-01

GORE® PROPATEN® Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K number K240083

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DSY 2024-01-17

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

Applicant Peca Labs, Inc.

K number K233783

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DSY 2024-01-09

GORE® PROPATEN® Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K number K232312

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DSY 2023-12-19

GORE® ACUSEAL Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K number K233551

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DSY 2023-06-23

GORE® ACUSEAL Vascular Graft

Applicant W. L. Gore & Associates, Inc.

K number K231505

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DSY 2022-08-15

HeRO Graft

Applicant Merit Medical Systems, Inc.

K number K213845

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DSY 2022-08-04

exGraft, exGraft Carbon

Applicant Peca Labs

K number K221628

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DSY 2021-05-25

HeRO Graft, HeRO Adapter

Applicant Merit Medical Systems, Inc.

K number K203724

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DSY 2021-04-06

Vascutek Gelsoft Plus ERS Vascular Graft

Applicant Vascutek, Ltd.

K number K202703

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DSY 2020-12-11

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft

Applicant Peca Labs

K number K202471

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DSY 2019-04-22

exGraft, exGraft Carbon

Applicant Peca Labs

K number K183613

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DSY 2018-08-21

exGraft, exGraft Carbon ePTFE Vascular Grafts

Applicant Peca Labs

K number K180957

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DSY 2017-11-30

HeRO Graft

Applicant Merit Medical Systems, Inc.

K number K172637

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DSY 2017-07-14

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

Applicant Vascutek, Ltd.

K number K162803

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DSY 2017-06-30

Gelweave Vascular Grafts

Applicant Vascutek, Ltd.

K number K162794

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DSY 2016-02-16

FUSION Vascular Graft

Applicant Maquet Cardiovascular, LLC

K number K153523

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DSY 2013-11-14

FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT

Applicant Maquet Cardiovascular, LLC

K number K131778

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DSY 2013-04-09

GORE ACUSEAL VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K130215

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DSY 2013-03-15

FLIXENE IFG VASCULAR GRAFT

Applicant Atrium Medical Corporation

K number K130142

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DSY 2013-03-07

HERO GRAFT

Applicant Hemoshpere, Inc., A Cryolife Company

K number K124039

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DSY 2013-02-05

LIFESPAN EPTFE VASCULAR GRAFT

Applicant LeMaitre Vascular, Inc.

K number K130016

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DSY 2012-08-17

ATRIUM FLIXENE IFG VASCULAR GRAFT

Applicant Atrium Medical Corp.

K number K122138

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DSY 2012-06-22

HERO GRAFT

Applicant Hemosphere, Inc.

K number K121532

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DSY 2012-02-02

HERO GRAFT

Applicant Hemosphere, Inc.

K number K120006

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DSY 2012-01-17

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL

Applicant Boston Scientific Corporation

K number K113101

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DSY 2011-02-02

CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES

Applicant Intervascular Sas

K number K103347

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DSY 2010-10-05

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT

Applicant Atrium Medical Corp.

K number K102596

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DSY 2010-03-23

SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT

Applicant Tayside Flow Technologies Limited

K number K094044

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DSY 2010-03-17

GORE HYBRID VASCULAR GRAFT

Applicant W.L. Gore & Associates

K number K093934

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DSY 2010-01-07

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS

Applicant Vascutek, Ltd.

K number K093817

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DSY 2009-10-08

MAXIFLO, TAPERFLO

Applicant Vascutek, Ltd.

K number K092863

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DSY 2009-08-31

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS

Applicant Vascutek, Ltd.

K number K091778

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DSY 2009-07-31

HERO VASCULAR ACCESS DEVICE

Applicant Hemosphere, Inc.

K number K091491

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DSY 2009-06-19

VASCUTEK BRANCHED GELWEAVE

Applicant Vascutek, Ltd.

K number K090987

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DSY 2009-03-30

EPTFE SLFTM SPIRAL VASCULAR GRAFT

Applicant Tayside Flow Technologies Limited

K number K083169

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DSY 2008-01-30

HERO VASCULAR ACCESS DEVICE

Applicant Graftcath, Inc.

K number K071778

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DSY 2007-08-14

PTFE FLIXENE GRADUATED WALL GRAFT

Applicant Atrium Medical Corp.

K number K071923

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DSY 2006-11-09

GORE PROPATEN VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K062161

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DSY 2006-10-05

VASORING* VRC VASCULAR RING CONNECTOR

Applicant Sunwei Tech Co. , Ltd.

K number K061626

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DSY 2006-04-05

SWIRLGRAFT VASCULAR ACCESS GRAFT

Applicant Veryan Medical Limited

K number K060741

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DSY 2006-03-30

ATRIUM FLIXENE GRAFT

Applicant Atrium Medical Corp.

K number K060124

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DSY 2006-02-07

VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS

Applicant Vascutek, Ltd.

K number K060142

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DSY 2006-01-06

EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN

Applicant Boston Scientific Corp

K number K052964

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DSY 2005-11-04

SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS

Applicant Veryan Medical Limited

K number K051312

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DSY 2005-09-29

ADVANTA T-GRAFT

Applicant Atrium Medical Corp.

K number K051332

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DSY 2005-09-20

VENAFLO II VASCULAR GRAFT

Applicant Bard Peripheral Vascular, Inc.

K number K052282

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DSY 2005-01-31

DYNAFLO BYPASS GRAFT

Applicant Bard Peripheral Vascular, Inc.

K number K050049

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DSY 2005-01-05

VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES

Applicant Vascutek, Ltd.

K number K043552

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DSY 2004-09-14

MODIFICATION TO EPTFE GRAFT

Applicant Vascutek, Ltd.

K number K041528

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DSY 2004-05-20

GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR

Applicant Vascutek, Ltd.

K number K040829

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DSY 2004-02-19

GELSOFT PLUS ERS

Applicant Vascutek, Ltd.

K number K034010

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DSY 2003-12-04

LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS

Applicant Edwards Lifesciences, LLC

K number K032900

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DSY 2003-04-09

EPTFE VASCULAR PROSTHESIS; SEALPTFE

Applicant Vascutek, Ltd.

K number K030999

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DSY 2003-01-24

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

Applicant Jotec GmbH

K number K021547

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DSY 2002-08-14

INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER

Applicant Intervascular

K number K022242

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DSY 2002-06-13

SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

Applicant Sulzer Carbomedics, Inc.

K number K013022

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DSY 2002-04-03

ADVANTA SST BIFURCATED GRAFT

Applicant Atrium Medical Corp.

K number K020767

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DSY 2002-02-27

INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

Applicant Intervascular

K number K013651

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DSY 2002-01-25

ULTRAMAX WOVEN VELOUR VASCULAR GRAFT

Applicant Atrium Medical Corp.

K number K013577

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DSY 2001-10-26

GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K013250

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DSY 2001-10-02

HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT

Applicant Boston Scientific/Medi-Tech

K number K012952

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DSY 2001-05-18

ADVANTA SST GRAFT (<6MM)

Applicant Atrium Medical Corp.

K number K010517

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DSY 2001-05-18

ADVANTA SST GRAFT (>_6MM)

Applicant Atrium Medical Corp.

K number K010516

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DSY 2001-03-27

IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS

Applicant Impra, Inc.

K number K004011

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DSY 2001-01-25

SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS

Applicant Sulzer Carbomedics, Inc.

K number K002007

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DSY 2001-01-08

INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS

Applicant Intervascular, Inc.

K number K990800

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DSY 2000-12-18

VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME

Applicant Thoratec Laboratories Corp.

K number K001927

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DSY 2000-03-01

ADVANTA SUPER SOFT GRAFT

Applicant Atrium Medical Corp.

K number K000499

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DSY 2000-01-28

SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS

Applicant Sulzermedica

K number K993667

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DSY 1999-12-09

SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS

Applicant Sulzermedica

K number K990503

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DSY 1999-11-19

SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS

Applicant Sulzermedica

K number K992832

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DSY 1999-10-01

ADVANTA GRAFT (>6MM)

Applicant Atrium Medical Corp.

K number K992960

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DSY 1999-08-20

ADVANTA GRAFT

Applicant Atrium Medical Corp.

K number K992443

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DSY 1999-07-09

EPTFE RINGED GORE-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K991602

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DSY 1999-06-01

UNI-GRAFT K DV VASCULAR GRAFT

Applicant Atrium Medical Corp.

K number K991813

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DSY 1999-04-22

BI-DIRECTIONAL TUNNELER

Applicant Impra, Inc.

K number K991027

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DSY 1999-02-22

MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

Applicant Intervascular, Inc.

K number K984294

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DSY 1999-02-01

PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452

Applicant Possis Medical, Inc.

K number K984182

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DSY 1998-11-24

DISTAFLO BYPASS GRAFT

Applicant Impra, Inc.

K number K983861

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DSY 1998-11-24

INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN

Applicant Intervascular, Inc.

K number K983819

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DSY 1998-11-19

IMPRA HIGH POROSITY GRAFT

Applicant Impra, Inc.

K number K983064

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DSY 1998-05-07

VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT

Applicant Impra, Inc.

K number K981079

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DSY 1997-07-21

UNI-GRAFT K DV

Applicant Atrium Medical Corp.

K number K963790

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DSY 1997-06-05

INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

Applicant Intervascular, Inc.

K number K970843

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DSY 1997-05-05

HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES

Applicant Intervascular, Inc.

K number K964625

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DSY 1997-04-15

IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT

Applicant Impra, Inc.

K number K971192

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DSY 1997-03-17

MEADOX EXXCEL EPTFE VASCULAR GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K962433

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DSY 1997-03-10

VASCUTEK TWILLWEAVE VASCULAR GRAFT

Applicant Vascutek, Ltd.

K number K964959

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DSY 1997-02-19

VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)

Applicant Carbomedics, Inc.

K number K964665

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DSY 1997-01-22

HEMASHIELD VANTAGE (VASCULAR GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K961847

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DSY 1997-01-02

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

Applicant Impra, Inc.

K number K964197

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DSY 1996-10-03

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

Applicant Impra, Inc.

K number K962639

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DSY 1996-06-19

BARD GRAFT SIZER

Applicant C.R. Bard, Inc.

K number K961134

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DSY 1996-05-30

MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K955460

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DSY 1996-04-25

VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT

Applicant Carbomedics, Inc.

K number K960706

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