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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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