FDA 510(k) Applications Submitted by Vascutek Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K060142 01/19/2006 VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS VASCUTEK LTD.
K070323 02/02/2007 TEMPORARY LIMB SALVAGE SHUNT VASCUTEK LTD.
K090987 04/07/2009 VASCUTEK BRANCHED GELWEAVE VASCUTEK LTD.
K081560 06/03/2008 VASCUTEK CANNULA GRAFT, MODEL CGS2008S VASCUTEK LTD.
K091778 06/17/2009 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS VASCUTEK LTD.
K092863 09/17/2009 MAXIFLO, TAPERFLO VASCUTEK LTD.
K093817 12/11/2009 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS VASCUTEK LTD.
K162794 10/04/2016 Gelweave Vascular Grafts VASCUTEK LTD.
K162803 10/05/2016 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts VASCUTEK LTD.
K241070 04/19/2024 GelsoftÖ Plus Vascular Prostheses Vascutek Ltd.
K241550 05/31/2024 GelweaveÖ Vascular Prostheses Vascutek Ltd.
K030999 03/31/2003 EPTFE VASCULAR PROSTHESIS; SEALPTFE VASCUTEK LTD.
K040829 03/31/2004 GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR VASCUTEK LTD.
K041528 06/08/2004 MODIFICATION TO EPTFE GRAFT VASCUTEK LTD.
K034010 12/24/2003 GELSOFT PLUS ERS VASCUTEK LTD.
K043552 12/27/2004 VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES VASCUTEK LTD.
K963611 09/10/1996 VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH VASCUTEK LTD.
K955230 11/14/1995 VASCUTEK GELSOFT PLUS VASCULAR GRAFT VASCUTEK LTD.
K964959 12/11/1996 VASCUTEK TWILLWEAVE VASCULAR GRAFT VASCUTEK LTD.


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