FDA Product Code
FDA Product Code DSY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3450
510(k) Clearances — 188 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | 2026-04-27 | Traditional | PDF ↗ |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | 2025-10-20 | Traditional | PDF ↗ |
| K241550 | Gelweave Vascular Prostheses | Vascutek, Ltd. | 2025-02-27 | Traditional | PDF ↗ |
| K241070 | Gelsoft Plus Vascular Prostheses | Vascutek, Ltd. | 2024-11-15 | Traditional | PDF ↗ |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | 2024-03-28 | Traditional | PDF ↗ |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-03-01 | Traditional | PDF ↗ |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | 2024-01-17 | Traditional | PDF ↗ |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | 2024-01-09 | Traditional | PDF ↗ |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-12-19 | Traditional | PDF ↗ |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | 2023-06-23 | Special | PDF ↗ |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | 2022-08-15 | Traditional | PDF ↗ |
| K221628 | exGraft, exGraft Carbon | Peca Labs | 2022-08-04 | Traditional | PDF ↗ |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | 2021-05-25 | Traditional | PDF ↗ |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Vascutek, Ltd. | 2021-04-06 | Traditional | PDF ↗ |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | 2020-12-11 | Traditional | PDF ↗ |
| K183613 | exGraft, exGraft Carbon | Peca Labs | 2019-04-22 | Traditional | PDF ↗ |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | 2018-08-21 | Traditional | PDF ↗ |
| K172637 | HeRO Graft | Merit Medical Systems, Inc. | 2017-11-30 | Traditional | PDF ↗ |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Vascutek, Ltd. | 2017-07-14 | Traditional | PDF ↗ |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | 2017-06-30 | Traditional | PDF ↗ |
| K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | 2016-02-16 | Traditional | PDF ↗ |
| K150389 | Spiral Flow Peripheral Vascular Graft | Vascular Flow Technologies, Ltd. | 2015-05-06 | Special | PDF ↗ |
| K142062 | SPIRAL FLOW PERIPHERAL VASCULAR GRAFT | Vascular Flow Technologies, Ltd. | 2014-11-20 | Special | PDF ↗ |
| K141124 | SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT | Vascular Flow Technologies, Ltd. | 2014-05-30 | Special | PDF ↗ |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | Maquet Cardiovascular, LLC | 2013-11-14 | Traditional | PDF ↗ |
| K130215 | GORE ACUSEAL VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K130142 | FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corporation | 2013-03-15 | Traditional | PDF ↗ |
| K124039 | HERO GRAFT | Hemoshpere, Inc., A Cryolife Company | 2013-03-07 | Traditional | PDF ↗ |
| K130016 | LIFESPAN EPTFE VASCULAR GRAFT | LeMaitre Vascular, Inc. | 2013-02-05 | Special | PDF ↗ |
| K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT | Atrium Medical Corp. | 2012-08-17 | Special | PDF ↗ |
| K121532 | HERO GRAFT | Hemosphere, Inc. | 2012-06-22 | Special | PDF ↗ |
| K120006 | HERO GRAFT | Hemosphere, Inc. | 2012-02-02 | Special | PDF ↗ |
| K113101 | EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL | Boston Scientific Corporation | 2012-01-17 | Traditional | PDF ↗ |
| K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Intervascular Sas | 2011-02-02 | Special | PDF ↗ |
| K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT | Atrium Medical Corp. | 2010-10-05 | Special | PDF ↗ |
| K094044 | SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT | Tayside Flow Technologies Limited | 2010-03-23 | Traditional | PDF ↗ |
| K093934 | GORE HYBRID VASCULAR GRAFT | W.L. Gore & Associates | 2010-03-17 | Traditional | PDF ↗ |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | Vascutek, Ltd. | 2010-01-07 | Special | PDF ↗ |
| K092863 | MAXIFLO, TAPERFLO | Vascutek, Ltd. | 2009-10-08 | Special | PDF ↗ |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | Vascutek, Ltd. | 2009-08-31 | Traditional | PDF ↗ |
| K091491 | HERO VASCULAR ACCESS DEVICE | Hemosphere, Inc. | 2009-07-31 | Special | PDF ↗ |
| K090987 | VASCUTEK BRANCHED GELWEAVE | Vascutek, Ltd. | 2009-06-19 | Traditional | PDF ↗ |
| K083169 | EPTFE SLFTM SPIRAL VASCULAR GRAFT | Tayside Flow Technologies Limited | 2009-03-30 | Traditional | PDF ↗ |
| K071778 | HERO VASCULAR ACCESS DEVICE | Graftcath, Inc. | 2008-01-30 | Traditional | PDF ↗ |
| K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | Atrium Medical Corp. | 2007-08-14 | Special | PDF ↗ |
| K062161 | GORE PROPATEN VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K061626 | VASORING* VRC VASCULAR RING CONNECTOR | Sunwei Tech Co. , Ltd. | 2006-10-05 | Traditional | PDF ↗ |
| K060741 | SWIRLGRAFT VASCULAR ACCESS GRAFT | Veryan Medical Limited | 2006-04-05 | Special | PDF ↗ |
| K060124 | ATRIUM FLIXENE GRAFT | Atrium Medical Corp. | 2006-03-30 | Special | PDF ↗ |
| K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS | Vascutek, Ltd. | 2006-02-07 | Special | PDF ↗ |
| K052964 | EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN | Boston Scientific Corp | 2006-01-06 | Traditional | PDF ↗ |
| K051312 | SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS | Veryan Medical Limited | 2005-11-04 | Traditional | PDF ↗ |
| K051332 | ADVANTA T-GRAFT | Atrium Medical Corp. | 2005-09-29 | Traditional | PDF ↗ |
| K052282 | VENAFLO II VASCULAR GRAFT | Bard Peripheral Vascular, Inc. | 2005-09-20 | Special | PDF ↗ |
| K050049 | DYNAFLO BYPASS GRAFT | Bard Peripheral Vascular, Inc. | 2005-01-31 | Special | PDF ↗ |
| K043552 | VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES | Vascutek, Ltd. | 2005-01-05 | Special | PDF ↗ |
| K041528 | MODIFICATION TO EPTFE GRAFT | Vascutek, Ltd. | 2004-09-14 | Traditional | PDF ↗ |
| K040829 | GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR | Vascutek, Ltd. | 2004-05-20 | Traditional | PDF ↗ |
| K034010 | GELSOFT PLUS ERS | Vascutek, Ltd. | 2004-02-19 | Traditional | PDF ↗ |
| K032900 | LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS | Edwards Lifesciences, LLC | 2003-12-04 | Traditional | PDF ↗ |
| K030999 | EPTFE VASCULAR PROSTHESIS; SEALPTFE | Vascutek, Ltd. | 2003-04-09 | Special | PDF ↗ |
| K021547 | FLOWLINE BIOPORE EPTFE VASCULAR GRAFT | Jotec GmbH | 2003-01-24 | Traditional | PDF ↗ |
| K022242 | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER | Intervascular | 2002-08-14 | Traditional | PDF ↗ |
| K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS | Sulzer Carbomedics, Inc. | 2002-06-13 | Traditional | PDF ↗ |
| K020767 | ADVANTA SST BIFURCATED GRAFT | Atrium Medical Corp. | 2002-04-03 | Special | PDF ↗ |
| K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS | Intervascular | 2002-02-27 | Traditional | PDF ↗ |
| K013577 | ULTRAMAX WOVEN VELOUR VASCULAR GRAFT | Atrium Medical Corp. | 2002-01-25 | Traditional | PDF ↗ |
| K013250 | GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 2001-10-26 | Special | PDF ↗ |
| K012952 | HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT | Boston Scientific/Medi-Tech | 2001-10-02 | Special | PDF ↗ |
| K010516 | ADVANTA SST GRAFT (>_6MM) | Atrium Medical Corp. | 2001-05-18 | Special | PDF ↗ |
| K010517 | ADVANTA SST GRAFT (<6MM) | Atrium Medical Corp. | 2001-05-18 | Special | PDF ↗ |
| K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | Impra, Inc. | 2001-03-27 | Traditional | PDF ↗ |
| K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS | Sulzer Carbomedics, Inc. | 2001-01-25 | Traditional | PDF ↗ |
| K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS | Intervascular, Inc. | 2001-01-08 | Traditional | PDF ↗ |
| K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME | Thoratec Laboratories Corp. | 2000-12-18 | Traditional | PDF ↗ |
| K000499 | ADVANTA SUPER SOFT GRAFT | Atrium Medical Corp. | 2000-03-01 | Special | PDF ↗ |
| K993667 | SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS | Sulzermedica | 2000-01-28 | Traditional | PDF ↗ |
| K990503 | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS | Sulzermedica | 1999-12-09 | Traditional | PDF ↗ |
| K992832 | SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS | Sulzermedica | 1999-11-19 | Traditional | PDF ↗ |
| K992960 | ADVANTA GRAFT (>6MM) | Atrium Medical Corp. | 1999-10-01 | Special | PDF ↗ |
| K992443 | ADVANTA GRAFT | Atrium Medical Corp. | 1999-08-20 | Special | PDF ↗ |
| K991602 | EPTFE RINGED GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K991813 | UNI-GRAFT K DV VASCULAR GRAFT | Atrium Medical Corp. | 1999-06-01 | Traditional | PDF ↗ |
| K991027 | BI-DIRECTIONAL TUNNELER | Impra, Inc. | 1999-04-22 | Special | PDF ↗ |
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Intervascular, Inc. | 1999-02-22 | Traditional | PDF ↗ |
| K984182 | PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 | Possis Medical, Inc. | 1999-02-01 | Traditional | PDF ↗ |
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | Intervascular, Inc. | 1998-11-24 | Special | PDF ↗ |
| K983861 | DISTAFLO BYPASS GRAFT | Impra, Inc. | 1998-11-24 | Abbreviated | PDF ↗ |
| K983064 | IMPRA HIGH POROSITY GRAFT | Impra, Inc. | 1998-11-19 | Traditional | PDF ↗ |
| K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | Impra, Inc. | 1998-05-07 | Traditional | PDF ↗ |
| K963790 | UNI-GRAFT K DV | Atrium Medical Corp. | 1997-07-21 | Traditional | PDF ↗ |
| K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Intervascular, Inc. | 1997-06-05 | Traditional | PDF ↗ |
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | Intervascular, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Impra, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-17 | Traditional | PDF ↗ |
| K964959 | VASCUTEK TWILLWEAVE VASCULAR GRAFT | Vascutek, Ltd. | 1997-03-10 | Traditional | PDF ↗ |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | Carbomedics, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1997-01-22 | Traditional | PDF ↗ |
| K964197 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT | Impra, Inc. | 1997-01-02 | Traditional | PDF ↗ |
| K962639 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT | Impra, Inc. | 1996-10-03 | Traditional | PDF ↗ |
Product code DSY · Class II · Cardiovascular. Data: openFDA.