Panels › Cardiovascular › Product code DSY · Class 2
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation 870.3450
1510(k)s in 12 months (188 all time)
2recalls in 12 months (87 all time)
86recalls that name a 510(k)
Top companies in DSY
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 27, 2026 | K252445 | Fusion Bioline Vascular Graft Maquet Cardiovascular, LLC | DSY |
| Oct 20, 2025 | K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) Vascular Flow Technologies Limited, GB | DSY |
| Feb 27, 2025 | K241550 | Gelweave Vascular Prostheses Vascutek, Ltd., GB | DSY |
| Nov 15, 2024 | K241070 | Gelsoft Plus Vascular Prostheses Vascutek, Ltd., GB | DSY |
| Mar 28, 2024 | K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft Atrium Medical Corporation | DSY |
| Mar 1, 2024 | K240083 | GORE® PROPATEN® Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Jan 17, 2024 | K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts Peca Labs, Inc. | DSY |
| Jan 9, 2024 | K232312 | GORE® PROPATEN® Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Dec 19, 2023 | K233551 | GORE® ACUSEAL Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Jun 23, 2023 | K231505 | GORE® ACUSEAL Vascular Graft W. L. Gore & Associates, Inc. | DSY |
| Aug 15, 2022 | K213845 | HeRO Graft Merit Medical Systems, Inc. | DSY |
| Aug 4, 2022 | K221628 | exGraft, exGraft Carbon Peca Labs | DSY |
| May 25, 2021 | K203724 | HeRO Graft, HeRO Adapter Merit Medical Systems, Inc. | DSY |
| Apr 6, 2021 | K202703 | Vascutek Gelsoft Plus ERS Vascular Graft Vascutek, Ltd., GB | DSY |
| Dec 11, 2020 | K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft Peca Labs | DSY |
| Apr 22, 2019 | K183613 | exGraft, exGraft Carbon Peca Labs | DSY |
| Aug 21, 2018 | K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts Peca Labs | DSY |
| Nov 30, 2017 | K172637 | HeRO Graft Merit Medical Systems, Inc. | DSY |
| Jul 14, 2017 | K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts Vascutek, Ltd., GB | DSY |
| Jun 30, 2017 | K162794 | Gelweave Vascular Grafts Vascutek, Ltd., GB | DSY |
| Feb 16, 2016 | K153523 | FUSION Vascular Graft Maquet Cardiovascular, LLC | DSY |
| May 6, 2015 | K150389 | Spiral Flow Peripheral Vascular Graft Vascular Flow Technologies, Ltd., GB | DSY |
| Nov 20, 2014 | K142062 | SPIRAL FLOW PERIPHERAL VASCULAR GRAFT Vascular Flow Technologies, Ltd., GB | DSY |
| May 30, 2014 | K141124 | SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT Vascular Flow Technologies, Ltd., GB | DSY |
| Nov 14, 2013 | K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT Maquet Cardiovascular, LLC | DSY |
| Apr 9, 2013 | K130215 | GORE ACUSEAL VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Mar 15, 2013 | K130142 | FLIXENE IFG VASCULAR GRAFT Atrium Medical Corporation | DSY |
| Mar 7, 2013 | K124039 | HERO GRAFT Hemoshpere, Inc., A Cryolife Company | DSY |
| Feb 5, 2013 | K130016 | LIFESPAN EPTFE VASCULAR GRAFT LeMaitre Vascular, Inc. | DSY |
| Aug 17, 2012 | K122138 | ATRIUM FLIXENE IFG VASCULAR GRAFT Atrium Medical Corp. | DSY |
| Jun 22, 2012 | K121532 | HERO GRAFT Hemosphere, Inc. | DSY |
| Feb 2, 2012 | K120006 | HERO GRAFT Hemosphere, Inc. | DSY |
| Jan 17, 2012 | K113101 | EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL Boston Scientific Corporation | DSY |
| Feb 2, 2011 | K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular Sas, FR | DSY |
| Oct 5, 2010 | K102596 | ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT Atrium Medical Corp. | DSY |
| Mar 23, 2010 | K094044 | SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT Tayside Flow Technologies Limited | DSY |
| Mar 17, 2010 | K093934 | GORE HYBRID VASCULAR GRAFT W.L. Gore & Associates | DSY |
| Jan 7, 2010 | K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS Vascutek, Ltd., GB | DSY |
| Oct 8, 2009 | K092863 | MAXIFLO, TAPERFLO Vascutek, Ltd., GB | DSY |
| Aug 31, 2009 | K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS Vascutek, Ltd., GB | DSY |
| Jul 31, 2009 | K091491 | HERO VASCULAR ACCESS DEVICE Hemosphere, Inc. | DSY |
| Jun 19, 2009 | K090987 | VASCUTEK BRANCHED GELWEAVE Vascutek, Ltd., GB | DSY |
| Mar 30, 2009 | K083169 | EPTFE SLFTM SPIRAL VASCULAR GRAFT Tayside Flow Technologies Limited | DSY |
| Jan 30, 2008 | K071778 | HERO VASCULAR ACCESS DEVICE Graftcath, Inc. | DSY |
| Aug 14, 2007 | K071923 | PTFE FLIXENE GRADUATED WALL GRAFT Atrium Medical Corp. | DSY |
| Nov 9, 2006 | K062161 | GORE PROPATEN VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Oct 5, 2006 | K061626 | VASORING* VRC VASCULAR RING CONNECTOR Sunwei Tech Co. , Ltd. | DSY |
| Apr 5, 2006 | K060741 | SWIRLGRAFT VASCULAR ACCESS GRAFT Veryan Medical Limited | DSY |
| Mar 30, 2006 | K060124 | ATRIUM FLIXENE GRAFT Atrium Medical Corp. | DSY |
| Feb 7, 2006 | K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS Vascutek, Ltd., GB | DSY |
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