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 |
| 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 |
| 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 |
| 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 |
| K961134 | C.R. BARD, INC. | BARD GRAFT SIZER | 06/19/1996 |
| 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 |
| K032900 | EDWARDS LIFESCIENCES, LLC. | LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS | 12/04/2003 |
| 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 |
| 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 |
| K984294 | INTERVASCULAR, INC. | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | 02/22/1999 |
| 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 |
| K961847 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. | HEMASHIELD VANTAGE (VASCULAR GRAFT | 01/22/1997 |
| K962433 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. | MEADOX EXXCEL EPTFE VASCULAR GRAFT | 03/17/1997 |
| K955460 | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT | 05/30/1996 |
| K172637 | Merit Medical Systems, Inc. | HeRO Graft | 11/30/2017 |
| K213845 | Merit Medical Systems, Inc. | HeRO Graft | 08/15/2022 |
| K203724 | Merit Medical Systems, Inc. | HeRO Graft, HeRO Adapter | 05/25/2021 |
| K202471 | PECA Labs | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | 12/11/2020 |
| K183613 | PECA Labs | exGraft, exGraft Carbon | 04/22/2019 |
| K221628 | PECA Labs | exGraft, exGraft Carbon | 08/04/2022 |
| K180957 | PECA Labs | exGraft, exGraft Carbon ePTFE Vascular Grafts | 08/21/2018 |
| K984182 | POSSIS MEDICAL, INC. | PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 | 02/01/1999 |
| 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 |
| 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 |
| K202703 | Vascutek Ltd | Vascutek Gelsoft Plus ERS Vascular Graft | 04/06/2021 |
| K030999 | VASCUTEK LTD. | EPTFE VASCULAR PROSTHESIS; SEALPTFE | 04/09/2003 |
| 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 |
| 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 |
| 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 |
| K231505 | W. L. Gore & Associates, Inc. | GORE« ACUSEAL Vascular Graft | 06/23/2023 |
| K093934 | W.L. GORE & ASSOCIATES | GORE HYBRID VASCULAR GRAFT | 03/17/2010 |
| 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 |
| 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 |
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