FDA 510(k) Applications for Medical Device Product Code "DSY"
(Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)

FDA 510(k) Number Applicant Device Name Decision Date
K771819 A&A ENT. CABG RINGS 10/21/1977
K862697 ADVANCED VASCULAR TECHNOLOGIES, INC. AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY) 12/05/1986
K890182 AESCULAP INSTRUMENTS CORP. PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV 02/28/1990
K882289 ARIES MEDICAL, INC. ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. 12/12/1988
K992443 ATRIUM MEDICAL CORP. ADVANTA GRAFT 08/20/1999
K992960 ATRIUM MEDICAL CORP. ADVANTA GRAFT (>6MM) 10/01/1999
K020767 ATRIUM MEDICAL CORP. ADVANTA SST BIFURCATED GRAFT 04/03/2002
K010517 ATRIUM MEDICAL CORP. ADVANTA SST GRAFT (<6MM) 05/18/2001
K010516 ATRIUM MEDICAL CORP. ADVANTA SST GRAFT (>_6MM) 05/18/2001
K000499 ATRIUM MEDICAL CORP. ADVANTA SUPER SOFT GRAFT 03/01/2000
K051332 ATRIUM MEDICAL CORP. ADVANTA T-GRAFT 09/29/2005
K060124 ATRIUM MEDICAL CORP. ATRIUM FLIXENE GRAFT 03/30/2006
K122138 ATRIUM MEDICAL CORP. ATRIUM FLIXENE IFG VASCULAR GRAFT 08/17/2012
K102596 ATRIUM MEDICAL CORP. ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT 10/05/2010
K853725 ATRIUM MEDICAL CORP. ATRIUM PLASMA TFE SYNTHETIC ARTERY 12/09/1985
K925123 ATRIUM MEDICAL CORP. ATRIUM'S HYBRID PTFE 05/27/1993
K071923 ATRIUM MEDICAL CORP. PTFE FLIXENE GRADUATED WALL GRAFT 08/14/2007
K013577 ATRIUM MEDICAL CORP. ULTRAMAX WOVEN VELOUR VASCULAR GRAFT 01/25/2002
K963790 ATRIUM MEDICAL CORP. UNI-GRAFT K DV 07/21/1997
K991813 ATRIUM MEDICAL CORP. UNI-GRAFT K DV VASCULAR GRAFT 06/01/1999
K130142 ATRIUM MEDICAL CORPORATION FLIXENE IFG VASCULAR GRAFT 03/15/2013
K050049 BARD PERIPHERAL VASCULAR, INC. DYNAFLO BYPASS GRAFT 01/31/2005
K052282 BARD PERIPHERAL VASCULAR, INC. VENAFLO II VASCULAR GRAFT 09/20/2005
K944858 BAXTER EDWARDS BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS 01/05/1995
K933590 BAXTER HEALTHCARE CORP. BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT 01/26/1994
K832806 BIOTRAC LABORATORIES CORONARY ANASTOMOSIS MARKING SYSTEM 09/29/1983
K052964 BOSTON SCIENTIFIC CORP. EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN 01/06/2006
K113101 Boston Scientific Corporation EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL 01/17/2012
K012952 BOSTON SCIENTIFIC/MEDI-TECH HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT 10/02/2001
K954582 C.R. BARD, INC. BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) 12/07/1995
K961134 C.R. BARD, INC. BARD GRAFT SIZER 06/19/1996
K933204 C.R. BARD, INC. BARD PTFE VASCULAR GRAFT 10/27/1993
K821716 C.R. BARD, INC. BARD PTFE VASCULAR PROSTHESIS 08/31/1982
K940816 C.R. BARD, INC. BARD(R) EXPANDED PTFE VASCULAR GRAFT 06/02/1994
K801156 C.R. BARD, INC. USCI INTRALUMINAL GRAFT W/DACRON TIE 05/23/1980
K800149 C.R. BARD, INC. USCI SAUVAGE EXS VASCULAR PROSTHESIS 02/28/1980
K964665 CARBOMEDICS, INC. VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) 02/19/1997
K955588 CARBOMEDICS, INC. VASCUTEK GRAFT SIZER SET 03/07/1996
K960706 CARBOMEDICS, INC. VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT 04/25/1996
K861808 COBE LABORATORIES, INC. VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN 09/15/1986
K853101 COBE LABORATORIES, INC. VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES 02/24/1986
K890597 D-R MEDICAL SYSTEMS, INC. EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS 09/26/1989
K880041 D-R MEDICAL SYSTEMS, INC. VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT 06/10/1988
K880040 D-R MEDICAL SYSTEMS, INC. VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT 06/09/1988
K871110 EDWARD WECK, INC. CORONARY ARTERY BYPASS GRAFT (CABG) MARKER 08/27/1987
K032900 EDWARDS LIFESCIENCES, LLC. LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS 12/04/2003
K820600 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. HANCOCK VASCULAR GRAFT 07/08/1982
K071778 GRAFTCATH INC. HERO VASCULAR ACCESS DEVICE 01/30/2008
K124039 HEMOSHPERE, INC., A CRYOLIFE COMPANY HERO GRAFT 03/07/2013
K120006 HEMOSPHERE INC HERO GRAFT 02/02/2012
K121532 HEMOSPHERE INC HERO GRAFT 06/22/2012
K091491 HEMOSPHERE INC HERO VASCULAR ACCESS DEVICE 07/31/2009
K991027 IMPRA, INC. BI-DIRECTIONAL TUNNELER 04/22/1999
K983861 IMPRA, INC. DISTAFLO BYPASS GRAFT 11/24/1998
K962639 IMPRA, INC. IMPRA CARBOFLO EPTFE VASCULAR GRAFT 10/03/1996
K964197 IMPRA, INC. IMPRA CARBOFLO EPTFE VASCULAR GRAFT 01/02/1997
K004011 IMPRA, INC. IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS 03/27/2001
K971192 IMPRA, INC. IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT 04/15/1997
K983064 IMPRA, INC. IMPRA HIGH POROSITY GRAFT 11/19/1998
K801621 IMPRA, INC. VASCULAR GRAFT PROSTH. OF EXP. MICRO. 09/09/1980
K830543 IMPRA, INC. VASCULAR GRAFT PROSTHESIS EXPANDED MICR 07/19/1983
K981079 IMPRA, INC. VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT 05/07/1998
K013651 INTERVASCULAR INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS 02/27/2002
K022242 INTERVASCULAR INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER 08/14/2002
K964625 INTERVASCULAR, INC. HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES 05/05/1997
K990800 INTERVASCULAR, INC. INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS 01/08/2001
K983819 INTERVASCULAR, INC. INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN 11/24/1998
K970843 INTERVASCULAR, INC. INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES 06/05/1997
K862739 INTERVASCULAR, INC. INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES 08/21/1986
K854845 INTERVASCULAR, INC. INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR 08/18/1986
K912911 INTERVASCULAR, INC. LOW POROSITY (LP) VASCULAR PROSTHESIS 09/23/1991
K833716 INTERVASCULAR, INC. LP200 & HP800 SERIES VASCULAR PROSTH 01/10/1984
K984294 INTERVASCULAR, INC. MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES 02/22/1999
K903964 INTERVASCULAR, INC. OCHSNER 50 BIFURCATION 12/03/1990
K905270 INTERVASCULAR, INC. OCHSNER 50 VASCULAR PROSTHESIS 02/15/1991
K905269 INTERVASCULAR, INC. OCHSNER 500 VASCULAR PROSTHESIS 04/02/1991
K913143 INTERVASCULAR, INC. OCHSNER ULP BIFURCATION VASCULAR PROTHESIS 10/23/1991
K870884 INTERVASCULAR, INC. RADIALLY-SUPPORTED VASCULAR PROSTHESES 02/05/1988
K103347 INTERVASCULAR, SAS CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES 02/02/2011
K021547 JOTEC GMBH FLOWLINE BIOPORE EPTFE VASCULAR GRAFT 01/24/2003
K130016 LEMAITRE VASCULAR, INC. LIFESPAN EPTFE VASCULAR GRAFT 02/05/2013
K131778 MAQUET CARDIOVASCULAR LLC FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT 11/14/2013
K153523 MAQUET CARDIOVASCULAR, LLC FUSION Vascular Graft 02/16/2016
K812248 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. COOLEY 2 VASCULAR PROSTHESIS STRAIGHT 11/24/1981
K810845 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. DOUBLE VELOUR GRAFTS 05/08/1981
K760090 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. GRAFT, COOLEY GUIDELINE, STERILE 07/20/1976
K760092 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. GRAFT, COOLEY WOVEN VASCULAR, STERILE 07/20/1976
K760091 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. GRAFT, MICROVEL GUIDELINE, STERILE 07/20/1976
K961847 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. HEMASHIELD VANTAGE (VASCULAR GRAFT 01/22/1997
K811441 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MANUFACTURING PROCESS CHANGE 09/16/1981
K841596 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOS INTRAORTIC GRAFT 05/08/1986
K962433 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX EXXCEL EPTFE VASCULAR GRAFT 03/17/1997
K881283 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX INTRA-AORTIC GRAFT 05/26/1988
K854431 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX MEDICALS INC. GRAFT SIZER 05/07/1986
K955460 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT 05/30/1996
K810376 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX SZILAGYI GRAFT 03/05/1981
K820696 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX WOVEN DOUBLE VELOUR 07/09/1982
K822633 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MICROVEL DOUBLE VELOUR SUPPORTED 100 07/12/1983
K882314 MED-EDGE, INC. CORONARY VEIN GRAFT MARKER 08/04/1988
K914116 MEDTRONIC VASCULAR PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION 11/27/1991
K893459 MEDTRONIC VASCULAR PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) 09/20/1989
K896964 MEDTRONIC VASCULAR PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC. 06/21/1990
K894732 MEDTRONIC VASCULAR VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) 10/12/1989
K172637 Merit Medical Systems, Inc. HeRO Graft 11/30/2017
K830016 PACESETTER SYSTEMS VASCUTEK VASCULAR PROTHESIS VP1200K/50K 12/21/1983
K180957 PECA Labs exGraft, exGraft Carbon ePTFE Vascular Grafts 08/21/2018
K922025 PIONEERING TECHNOLOGIES, INC. ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF 09/22/1992
K905067 PIONEERING TECHNOLOGIES, INC. PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT 03/18/1991
K901682 PIONEERING TECHNOLOGIES, INC. PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS 07/03/1990
K984182 POSSIS MEDICAL, INC. PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 02/01/1999
K791828 SHILEY, INC. BJORK-SHILEY PULMONIC GRAFT VALVE 09/27/1979
K803000 SHILEY, INC. IONESCU-SHILEY AORTIC GRAFT VALVE 02/02/1981
K831880 SHILEY, INC. IONESCU-SHILEY LOW POROSITY AORTIC GRAFT 10/19/1983
K831865 SHILEY, INC. IONESCU-SHILEY LOW POROSITY COMPOSITE 10/19/1983
K831822 SHILEY, INC. TETRAFLEX INTEGRALLY SUPPORTED PTFE 10/16/1984
K002007 SULZER CARBOMEDICS, INC. SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS 01/25/2001
K013022 SULZER CARBOMEDICS, INC. SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS 06/13/2002
K992832 SULZER MEDICA SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS 11/19/1999
K993667 SULZER MEDICA SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS 01/28/2000
K990503 SULZERMEDICA SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS 12/09/1999
K061626 SUNWEI TECH CO. LTD. VASORING* VRC VASCULAR RING CONNECTOR 10/05/2006
K083169 TAYSIDE FLOW TECHNOLOGIES LIMITED EPTFE SLFTM SPIRAL VASCULAR GRAFT 03/30/2009
K094044 TAYSIDE FLOW TECHNOLOGIES LIMITED SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT 03/23/2010
K001927 THORATEC LABORATORIES CORP. VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME 12/18/2000
K884083 TORAY INDUSTRIES (AMERICA), INC. TORAY VASCULAR PROSTHESIS 01/12/1989
K770235 USCI, DIV. C.R. BARD, INC. DEBAKEY VASCULOUR-D PROSTHESES 02/24/1977
K760130 USCI, DIV. C.R. BARD, INC. PROSTHESIS, VASCULAR BIFURCATED 07/20/1976
K770236 USCI, DIV. C.R. BARD, INC. SAUVAGE FILAMENTOUS PROSTHESES 02/25/1977
K142062 VASCULAR FLOW TECHNOLOGIES LTD SPIRAL FLOW PERIPHERAL VASCULAR GRAFT 11/20/2014
K150389 VASCULAR FLOW TECHNOLOGIES LTD Spiral Flow Peripheral Vascular Graft 05/06/2015
K141124 VASCULAR FLOW TECHNOLOGIES LTD SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT 05/30/2014
K030999 VASCUTEK LTD. EPTFE VASCULAR PROSTHESIS; SEALPTFE 04/09/2003
K910864 VASCUTEK LTD. EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS 04/01/1991
K910863 VASCUTEK LTD. EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS 04/01/1991
K162803 VASCUTEK LTD. Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts 07/14/2017
K034010 VASCUTEK LTD. GELSOFT PLUS ERS 02/19/2004
K040829 VASCUTEK LTD. GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR 05/20/2004
K093817 VASCUTEK LTD. GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS 01/07/2010
K162794 VASCUTEK LTD. Gelweave Vascular Grafts 06/30/2017
K092863 VASCUTEK LTD. MAXIFLO, TAPERFLO 10/08/2009
K041528 VASCUTEK LTD. MODIFICATION TO EPTFE GRAFT 09/14/2004
K910865 VASCUTEK LTD. TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS 04/01/1991
K910866 VASCUTEK LTD. VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS 04/01/1991
K090987 VASCUTEK LTD. VASCUTEK BRANCHED GELWEAVE 06/19/2009
K091778 VASCUTEK LTD. VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS 08/31/2009
K955230 VASCUTEK LTD. VASCUTEK GELSOFT PLUS VASCULAR GRAFT 02/09/1996
K060142 VASCUTEK LTD. VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS 02/07/2006
K952293 VASCUTEK LTD. VASCUTEK GELWEAVE VASCULAR GRAFT 12/19/1995
K043552 VASCUTEK LTD. VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES 01/05/2005
K964959 VASCUTEK LTD. VASCUTEK TWILLWEAVE VASCULAR GRAFT 03/10/1997
K051312 VERYAN MEDICAL LIMITED SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS 11/04/2005
K060741 VERYAN MEDICAL LIMITED SWIRLGRAFT VASCULAR ACCESS GRAFT 04/05/2006
K013250 W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT 10/26/2001
K093934 W.L. GORE & ASSOCIATES GORE HYBRID VASCULAR GRAFT 03/17/2010
K933987 W.L. GORE & ASSOCIATES,INC AOR-TEX VASCULAR GRAFT 05/17/1994
K941981 W.L. GORE & ASSOCIATES,INC AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED 07/20/1994
K901641 W.L. GORE & ASSOCIATES,INC AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT 09/05/1990
K904282 W.L. GORE & ASSOCIATES,INC BIFURCATED GORE TEX STRETCH VASCULAR GRAFT 01/16/1991
K940062 W.L. GORE & ASSOCIATES,INC DIASTAT VASCULAR ACCESS GRAFT 05/02/1994
K953288 W.L. GORE & ASSOCIATES,INC DIASTAT VASCULAR ACCESS GRAFT 10/06/1995
K955532 W.L. GORE & ASSOCIATES,INC DIASTAT VASCULAR ACCESS GRAFT 03/11/1996
K991602 W.L. GORE & ASSOCIATES,INC EPTFE RINGED GORE-TEX VASCULAR GRAFT 07/09/1999
K821158 W.L. GORE & ASSOCIATES,INC FED RINGED-TEX VASCULAR GRAFT 05/18/1982
K933943 W.L. GORE & ASSOCIATES,INC FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS 12/08/1993
K922905 W.L. GORE & ASSOCIATES,INC FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT 11/24/1992
K130215 W.L. GORE & ASSOCIATES,INC GORE ACUSEAL VASCULAR GRAFT 04/09/2013
K062161 W.L. GORE & ASSOCIATES,INC GORE PROPATEN VASCULAR GRAFT 11/09/2006
K802095 W.L. GORE & ASSOCIATES,INC GORE-TEX VASCULAR GRAFT 10/10/1980
K880167 W.L. GORE & ASSOCIATES,INC GORE-TEX VASCULAR GRAFT 05/18/1988
K811510 W.L. GORE & ASSOCIATES,INC GORE-TEX VASULAR GRAFT 08/20/1981
K903931 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) STRETCH VASCULAR GRAFT 12/06/1990
K914447 W.L. GORE & ASSOCIATES,INC GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE 11/05/1991


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact