Vascutek, Ltd. - FDA 510(k) Cleared Devices
26
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by Vascutek, Ltd. Cardiovascular ✕
26 devices
Cleared
Feb 27, 2025
Gelweave™ Vascular Prostheses
Cardiovascular
272d
Cleared
Nov 15, 2024
Gelsoft™ Plus Vascular Prostheses
Cardiovascular
210d
Cleared
Apr 06, 2021
Vascutek Gelsoft Plus ERS Vascular Graft
Cardiovascular
202d
Cleared
Jul 08, 2020
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
Cardiovascular
90d
Cleared
Jul 14, 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
Cardiovascular
282d
Cleared
Jun 30, 2017
Gelweave Vascular Grafts
Cardiovascular
269d
Cleared
Jan 07, 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
Cardiovascular
27d
Cleared
Oct 08, 2009
MAXIFLO, TAPERFLO
Cardiovascular
21d
Cleared
Aug 31, 2009
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
Cardiovascular
75d
Cleared
Jun 19, 2009
VASCUTEK BRANCHED GELWEAVE
Cardiovascular
73d
Cleared
Feb 10, 2009
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
Cardiovascular
252d
Cleared
Feb 15, 2007
TEMPORARY LIMB SALVAGE SHUNT
Cardiovascular
13d