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Vascutek, Ltd.

FDA 510(k) & PMA Approved Devices — 26 products

Total Devices26
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241550 Gelweave™ Vascular ProsthesesDSY2025-02-27 View
510(k) K241070 Gelsoft™ Plus Vascular ProsthesesDSY2024-11-15 View
510(k) K202703 Vascutek Gelsoft Plus ERS Vascular GraftDSY2021-04-06 View
510(k) K200955 Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ2020-07-08 View
510(k) K162803 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsDSY2017-07-14 View
510(k) K162794 Gelweave Vascular GraftsDSY2017-06-30 View
510(k) K093817 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERSDSY2010-01-07 View
510(k) K092863 MAXIFLO, TAPERFLODSY2009-10-08 View
510(k) K091778 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTSDSY2009-08-31 View
510(k) K090987 VASCUTEK BRANCHED GELWEAVEDSY2009-06-19 View
510(k) K081560 VASCUTEK CANNULA GRAFT, MODEL CGS2008SDWF2009-02-10 View
510(k) K070323 TEMPORARY LIMB SALVAGE SHUNTDXC2007-02-15 View
510(k) K060142 VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERSDSY2006-02-07 View
510(k) K043552 VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESESDSY2005-01-05 View
510(k) K041528 MODIFICATION TO EPTFE GRAFTDSY2004-09-14 View
510(k) K040829 GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLARDSY2004-05-20 View
510(k) K034010 GELSOFT PLUS ERSDSY2004-02-19 View
510(k) K030999 EPTFE VASCULAR PROSTHESIS; SEALPTFEDSY2003-04-09 View
510(k) K964959 VASCUTEK TWILLWEAVE VASCULAR GRAFTDSY1997-03-10 View
510(k) K963611 VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCHDXZ1996-11-21 View
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