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 |
|---|---|---|---|
| Jan 6, 2006 | K052964 | EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN Boston Scientific Corp | DSY |
| Nov 4, 2005 | K051312 | SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS Veryan Medical Limited | DSY |
| Sep 29, 2005 | K051332 | ADVANTA T-GRAFT Atrium Medical Corp. | DSY |
| Sep 20, 2005 | K052282 | VENAFLO II VASCULAR GRAFT Bard Peripheral Vascular, Inc. | DSY |
| Jan 31, 2005 | K050049 | DYNAFLO BYPASS GRAFT Bard Peripheral Vascular, Inc. | DSY |
| Jan 5, 2005 | K043552 | VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES Vascutek, Ltd. | DSY |
| Sep 14, 2004 | K041528 | MODIFICATION TO EPTFE GRAFT Vascutek, Ltd. | DSY |
| May 20, 2004 | K040829 | GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR Vascutek, Ltd. | DSY |
| Feb 19, 2004 | K034010 | GELSOFT PLUS ERS Vascutek, Ltd. | DSY |
| Dec 4, 2003 | K032900 | LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS Edwards Lifesciences, LLC | DSY |
| Apr 9, 2003 | K030999 | EPTFE VASCULAR PROSTHESIS; SEALPTFE Vascutek, Ltd. | DSY |
| Jan 24, 2003 | K021547 | FLOWLINE BIOPORE EPTFE VASCULAR GRAFT Jotec GmbH | DSY |
| Aug 14, 2002 | K022242 | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER Intervascular | DSY |
| Jun 13, 2002 | K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. | DSY |
| Apr 3, 2002 | K020767 | ADVANTA SST BIFURCATED GRAFT Atrium Medical Corp. | DSY |
| Feb 27, 2002 | K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS Intervascular | DSY |
| Jan 25, 2002 | K013577 | ULTRAMAX WOVEN VELOUR VASCULAR GRAFT Atrium Medical Corp. | DSY |
| Oct 26, 2001 | K013250 | GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Oct 2, 2001 | K012952 | HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT Boston Scientific/Medi-Tech | DSY |
| May 18, 2001 | K010517 | ADVANTA SST GRAFT (<6MM) Atrium Medical Corp. | DSY |
| May 18, 2001 | K010516 | ADVANTA SST GRAFT (>_6MM) Atrium Medical Corp. | DSY |
| Mar 27, 2001 | K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS Impra, Inc. | DSY |
| Jan 25, 2001 | K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS Sulzer Carbomedics, Inc. | DSY |
| Jan 8, 2001 | K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS Intervascular, Inc. | DSY |
| Dec 18, 2000 | K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME Thoratec Laboratories Corp. | DSY |
| Mar 1, 2000 | K000499 | ADVANTA SUPER SOFT GRAFT Atrium Medical Corp. | DSY |
| Jan 28, 2000 | K993667 | SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS Sulzermedica | DSY |
| Dec 9, 1999 | K990503 | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS Sulzermedica | DSY |
| Nov 19, 1999 | K992832 | SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS Sulzermedica | DSY |
| Oct 1, 1999 | K992960 | ADVANTA GRAFT (>6MM) Atrium Medical Corp. | DSY |
| Aug 20, 1999 | K992443 | ADVANTA GRAFT Atrium Medical Corp. | DSY |
| Jul 9, 1999 | K991602 | EPTFE RINGED GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. | DSY |
| Jun 1, 1999 | K991813 | UNI-GRAFT K DV VASCULAR GRAFT Atrium Medical Corp. | DSY |
| Apr 22, 1999 | K991027 | BI-DIRECTIONAL TUNNELER Impra, Inc. | DSY |
| Feb 22, 1999 | K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular, Inc. | DSY |
| Feb 1, 1999 | K984182 | PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452 Possis Medical, Inc. | DSY |
| Nov 24, 1998 | K983861 | DISTAFLO BYPASS GRAFT Impra, Inc. | DSY |
| Nov 24, 1998 | K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN Intervascular, Inc. | DSY |
| Nov 19, 1998 | K983064 | IMPRA HIGH POROSITY GRAFT Impra, Inc. | DSY |
| May 7, 1998 | K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT Impra, Inc. | DSY |
| Jul 21, 1997 | K963790 | UNI-GRAFT K DV Atrium Medical Corp. | DSY |
| Jun 5, 1997 | K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES Intervascular, Inc. | DSY |
| May 5, 1997 | K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES Intervascular, Inc. | DSY |
| Apr 15, 1997 | K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT Impra, Inc. | DSY |
| Mar 17, 1997 | K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Mar 10, 1997 | K964959 | VASCUTEK TWILLWEAVE VASCULAR GRAFT Vascutek, Ltd. | DSY |
| Feb 19, 1997 | K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) Carbomedics, Inc. | DSY |
| Jan 22, 1997 | K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. | DSY |
| Jan 2, 1997 | K964197 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. | DSY |
| Oct 3, 1996 | K962639 | IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. | DSY |
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