Medical Device Manufacturer · GB , Pa49rr Scotland

Vascutek, Ltd.

26 submissions · 23 cleared · Since 1991
26
Total
23
Cleared
0
Denied

Vascutek, Ltd. — FDA 510(k) Submissions

Vascutek, Ltd. has submitted 26 FDA 510(k) premarket notifications since 1991, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, Clamp, Vascular, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
Gelweave? Vascular Prostheses
K241550 · DSY Prosthesis, Vascular... · Cardiovascular
Feb 2025 272d
Gelsoft? Plus Vascular Prostheses
K241070 · DSY Prosthesis, Vascular... · Cardiovascular
Nov 2024 210d
Vascutek Gelsoft Plus ERS Vascular Graft
K202703 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 2021 202d
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · DXZ Patch, Pledget And... · Cardiovascular
Jul 2020 90d
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · DSY Prosthesis, Vascular... · Cardiovascular
Jul 2017 282d
Gelweave Vascular Grafts
K162794 · DSY Prosthesis, Vascular... · Cardiovascular
Jun 2017 269d
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · DSY Prosthesis, Vascular... · Cardiovascular
Jan 2010 27d
MAXIFLO, TAPERFLO
K092863 · DSY Prosthesis, Vascular... · Cardiovascular
Oct 2009 21d
VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
K091778 · DSY Prosthesis, Vascular... · Cardiovascular
Aug 2009 75d
VASCUTEK BRANCHED GELWEAVE
K090987 · DSY Prosthesis, Vascular... · Cardiovascular
Jun 2009 73d
VASCUTEK CANNULA GRAFT, MODEL CGS2008S
K081560 · DWF Catheter, Cannula And... · Cardiovascular
Feb 2009 252d
TEMPORARY LIMB SALVAGE SHUNT
K070323 · DXC Clamp, Vascular · Cardiovascular
Feb 2007 13d
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142 · DSY Prosthesis, Vascular... · Cardiovascular
Feb 2006 19d
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · DSY Prosthesis, Vascular... · Cardiovascular
Jan 2005 9d
MODIFICATION TO EPTFE GRAFT
K041528 · DSY Prosthesis, Vascular... · Cardiovascular
Sep 2004 98d
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829 · DSY Prosthesis, Vascular... · Cardiovascular
May 2004 50d
GELSOFT PLUS ERS
K034010 · DSY Prosthesis, Vascular... · Cardiovascular
Feb 2004 57d
EPTFE VASCULAR PROSTHESIS; SEALPTFE
K030999 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 2003 9d
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · DSY Prosthesis, Vascular... · Cardiovascular
Mar 1997 89d
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
K963611 · DXZ Patch, Pledget And... · Cardiovascular
Nov 1996 72d
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230 · DSY Prosthesis, Vascular... · Cardiovascular
Feb 1996 87d
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · DSY Prosthesis, Vascular... · Cardiovascular
Dec 1995 217d
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 1991 31d
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 1991 31d
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · DSY Prosthesis, Vascular... · Cardiovascular
Apr 1991 31d
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