| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
| HeRO Graft, HeRO Adapter (K203724) | Merit Medical Systems, Inc. | 2021-05-25 |
| Vascutek Gelsoft Plus ERS Vascular Graft (K202703) | Vascutek, Ltd. | 2021-04-06 |
| exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (K202471) | Peca Labs | 2020-12-11 |
| exGraft, exGraft Carbon (K183613) | Peca Labs | 2019-04-22 |
| exGraft, exGraft Carbon ePTFE Vascular Grafts (K180957) | Peca Labs | 2018-08-21 |
| HeRO Graft (K172637) | Merit Medical Systems, Inc. | 2017-11-30 |
| Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) | Vascutek, Ltd. | 2017-07-14 |
| Gelweave Vascular Grafts (K162794) | Vascutek, Ltd. | 2017-06-30 |
| FUSION Vascular Graft (K153523) | Maquet Cardiovascular, LLC | 2016-02-16 |
| Spiral Flow Peripheral Vascular Graft (K150389) | Vascular Flow Technologies, Ltd. | 2015-05-06 |
| SPIRAL FLOW PERIPHERAL VASCULAR GRAFT (K142062) | Vascular Flow Technologies, Ltd. | 2014-11-20 |
| SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT (K141124) | Vascular Flow Technologies, Ltd. | 2014-05-30 |
| FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (K131778) | Maquet Cardiovascular, LLC | 2013-11-14 |
| GORE ACUSEAL VASCULAR GRAFT (K130215) | W. L. Gore & Associates, Inc. | 2013-04-09 |
| FLIXENE IFG VASCULAR GRAFT (K130142) | Atrium Medical Corporation | 2013-03-15 |
| HERO GRAFT (K124039) | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 |
| LIFESPAN EPTFE VASCULAR GRAFT (K130016) | LeMaitre Vascular, Inc. | 2013-02-05 |
| ATRIUM FLIXENE IFG VASCULAR GRAFT (K122138) | Atrium Medical Corp. | 2012-08-17 |
| HERO GRAFT (K121532) | Hemosphere, Inc. | 2012-06-22 |
| HERO GRAFT (K120006) | Hemosphere, Inc. | 2012-02-02 |
| EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL (K113101) | Boston Scientific Corporation | 2012-01-17 |
| CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K103347) | Intervascular Sas | 2011-02-02 |
| ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (K102596) | Atrium Medical Corp. | 2010-10-05 |
| SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT (K094044) | Tayside Flow Technologies Limited | 2010-03-23 |
| GORE HYBRID VASCULAR GRAFT (K093934) | W.L. Gore & Associates | 2010-03-17 |
| GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (K093817) | Vascutek, Ltd. | 2010-01-07 |
| MAXIFLO, TAPERFLO (K092863) | Vascutek, Ltd. | 2009-10-08 |
| VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (K091778) | Vascutek, Ltd. | 2009-08-31 |
| HERO VASCULAR ACCESS DEVICE (K091491) | Hemosphere, Inc. | 2009-07-31 |
| VASCUTEK BRANCHED GELWEAVE (K090987) | Vascutek, Ltd. | 2009-06-19 |
| EPTFE SLFTM SPIRAL VASCULAR GRAFT (K083169) | Tayside Flow Technologies Limited | 2009-03-30 |
| HERO VASCULAR ACCESS DEVICE (K071778) | Graftcath, Inc. | 2008-01-30 |
| PTFE FLIXENE GRADUATED WALL GRAFT (K071923) | Atrium Medical Corp. | 2007-08-14 |
| GORE PROPATEN VASCULAR GRAFT (K062161) | W. L. Gore & Associates, Inc. | 2006-11-09 |
| VASORING* VRC VASCULAR RING CONNECTOR (K061626) | Sunwei Tech Co. , Ltd. | 2006-10-05 |
| SWIRLGRAFT VASCULAR ACCESS GRAFT (K060741) | Veryan Medical Limited | 2006-04-05 |
| ATRIUM FLIXENE GRAFT (K060124) | Atrium Medical Corp. | 2006-03-30 |
| VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS (K060142) | Vascutek, Ltd. | 2006-02-07 |
| EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN (K052964) | Boston Scientific Corp | 2006-01-06 |
| SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS (K051312) | Veryan Medical Limited | 2005-11-04 |
| ADVANTA T-GRAFT (K051332) | Atrium Medical Corp. | 2005-09-29 |
| VENAFLO II VASCULAR GRAFT (K052282) | Bard Peripheral Vascular, Inc. | 2005-09-20 |
| DYNAFLO BYPASS GRAFT (K050049) | Bard Peripheral Vascular, Inc. | 2005-01-31 |
| VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES (K043552) | Vascutek, Ltd. | 2005-01-05 |
| MODIFICATION TO EPTFE GRAFT (K041528) | Vascutek, Ltd. | 2004-09-14 |
| GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR (K040829) | Vascutek, Ltd. | 2004-05-20 |
| GELSOFT PLUS ERS (K034010) | Vascutek, Ltd. | 2004-02-19 |
| LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS (K032900) | Edwards Lifesciences, LLC | 2003-12-04 |
| EPTFE VASCULAR PROSTHESIS; SEALPTFE (K030999) | Vascutek, Ltd. | 2003-04-09 |
| FLOWLINE BIOPORE EPTFE VASCULAR GRAFT (K021547) | Jotec GmbH | 2003-01-24 |
| INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER (K022242) | Intervascular | 2002-08-14 |
| SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS (K013022) | Sulzer Carbomedics, Inc. | 2002-06-13 |
| ADVANTA SST BIFURCATED GRAFT (K020767) | Atrium Medical Corp. | 2002-04-03 |
| INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS (K013651) | Intervascular | 2002-02-27 |
| ULTRAMAX WOVEN VELOUR VASCULAR GRAFT (K013577) | Atrium Medical Corp. | 2002-01-25 |
| GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT (K013250) | W. L. Gore & Associates, Inc. | 2001-10-26 |
| HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT (K012952) | Boston Scientific/Medi-Tech | 2001-10-02 |
| ADVANTA SST GRAFT (<6MM) (K010517) | Atrium Medical Corp. | 2001-05-18 |
| ADVANTA SST GRAFT (>_6MM) (K010516) | Atrium Medical Corp. | 2001-05-18 |
| IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (K004011) | Impra, Inc. | 2001-03-27 |
| SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS (K002007) | Sulzer Carbomedics, Inc. | 2001-01-25 |
| INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS (K990800) | Intervascular, Inc. | 2001-01-08 |
| VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME (K001927) | Thoratec Laboratories Corp. | 2000-12-18 |
| ADVANTA SUPER SOFT GRAFT (K000499) | Atrium Medical Corp. | 2000-03-01 |
| SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS (K993667) | Sulzermedica | 2000-01-28 |
| SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS (K990503) | Sulzermedica | 1999-12-09 |
| SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS (K992832) | Sulzermedica | 1999-11-19 |
| ADVANTA GRAFT (>6MM) (K992960) | Atrium Medical Corp. | 1999-10-01 |
| ADVANTA GRAFT (K992443) | Atrium Medical Corp. | 1999-08-20 |
| EPTFE RINGED GORE-TEX VASCULAR GRAFT (K991602) | W. L. Gore & Associates, Inc. | 1999-07-09 |
| UNI-GRAFT K DV VASCULAR GRAFT (K991813) | Atrium Medical Corp. | 1999-06-01 |
| BI-DIRECTIONAL TUNNELER (K991027) | Impra, Inc. | 1999-04-22 |
| MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K984294) | Intervascular, Inc. | 1999-02-22 |
| PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 (K984182) | Possis Medical, Inc. | 1999-02-01 |
| DISTAFLO BYPASS GRAFT (K983861) | Impra, Inc. | 1998-11-24 |
| INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN (K983819) | Intervascular, Inc. | 1998-11-24 |
| IMPRA HIGH POROSITY GRAFT (K983064) | Impra, Inc. | 1998-11-19 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981079) | Impra, Inc. | 1998-05-07 |
| UNI-GRAFT K DV (K963790) | Atrium Medical Corp. | 1997-07-21 |
| INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K970843) | Intervascular, Inc. | 1997-06-05 |
| HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES (K964625) | Intervascular, Inc. | 1997-05-05 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K971192) | Impra, Inc. | 1997-04-15 |
| MEADOX EXXCEL EPTFE VASCULAR GRAFT (K962433) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-17 |
| VASCUTEK TWILLWEAVE VASCULAR GRAFT (K964959) | Vascutek, Ltd. | 1997-03-10 |
| VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (K964665) | Carbomedics, Inc. | 1997-02-19 |
| HEMASHIELD VANTAGE (VASCULAR GRAFT (K961847) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 |
| IMPRA CARBOFLO EPTFE VASCULAR GRAFT (K964197) | Impra, Inc. | 1997-01-02 |
| IMPRA CARBOFLO EPTFE VASCULAR GRAFT (K962639) | Impra, Inc. | 1996-10-03 |