Company · GB
Vascutek, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2025. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
6recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2025 | K241550 | Gelweave Vascular Prostheses Vascutek, Ltd., GB | DSY |
| Nov 15, 2024 | K241070 | Gelsoft Plus Vascular Prostheses Vascutek, Ltd., GB | DSY |
| Apr 6, 2021 | K202703 | Vascutek Gelsoft Plus ERS Vascular Graft Vascutek, Ltd., GB | DSY |
| Jul 8, 2020 | K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch Vascutek, Ltd., GB | DXZ |
| Jul 14, 2017 | K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts Vascutek, Ltd., GB | DSY |
| Jun 30, 2017 | K162794 | Gelweave Vascular Grafts Vascutek, Ltd., GB | DSY |
| Jan 7, 2010 | K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS Vascutek, Ltd., GB | DSY |
| Oct 8, 2009 | K092863 | MAXIFLO, TAPERFLO Vascutek, Ltd., GB | DSY |
| Aug 31, 2009 | K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS Vascutek, Ltd., GB | DSY |
| Jun 19, 2009 | K090987 | VASCUTEK BRANCHED GELWEAVE Vascutek, Ltd., GB | DSY |
| Feb 10, 2009 | K081560 | VASCUTEK CANNULA GRAFT, MODEL CGS2008S Vascutek, Ltd., GB | DWF |
| Feb 15, 2007 | K070323 | TEMPORARY LIMB SALVAGE SHUNT Vascutek, Ltd., GB | DXC |
| Feb 7, 2006 | K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS Vascutek, Ltd., GB | DSY |
| Jan 5, 2005 | K043552 | VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES Vascutek, Ltd. | DSY |
| Sep 14, 2004 | K041528 | MODIFICATION TO EPTFE GRAFT Vascutek, Ltd. | DSY |
| May 20, 2004 | K040829 | GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR Vascutek, Ltd. | DSY |
| Feb 19, 2004 | K034010 | GELSOFT PLUS ERS Vascutek, Ltd. | DSY |
| Apr 9, 2003 | K030999 | EPTFE VASCULAR PROSTHESIS; SEALPTFE Vascutek, Ltd. | DSY |
| Mar 10, 1997 | K964959 | VASCUTEK TWILLWEAVE VASCULAR GRAFT Vascutek, Ltd. | DSY |
| Nov 21, 1996 | K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH Vascutek, Ltd. | DXZ |
| Feb 9, 1996 | K955230 | VASCUTEK GELSOFT PLUS VASCULAR GRAFT Vascutek, Ltd. | DSY |
| Dec 19, 1995 | K952293 | VASCUTEK GELWEAVE VASCULAR GRAFT Vascutek, Ltd. | DSY |
| Apr 1, 1991 | K910866 | VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS Vascutek, Ltd., GB | DSY |
| Apr 1, 1991 | K910865 | TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS Vascutek, Ltd., GB | DSY |
| Apr 1, 1991 | K910864 | EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS Vascutek, Ltd., GB | DSY |
| Apr 1, 1991 | K910863 | EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS Vascutek, Ltd., GB | DSY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2026 | Vascutek, Ltd. Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, Open, Classified |
DSY | K241070 K241550 |
| Jul 8, 2021 | Vascutek, Ltd. The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches.
FSN says Tapered Carotid Patch 920875t Terminated |
DXZ | K963611 K972201 |
| Jul 8, 2021 | Vascutek, Ltd. The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular graft Terminated |
DSY | K013022 K034010 +2 |
| Jun 26, 2015 | Vascutek, Ltd. Gelseal Straight Diameter 8mm Length 30cm.
Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cere Terminated |
MAL | None listed |
| Jun 26, 2015 | Vascutek, Ltd. Gelseal Straight Diameter 8mm Length 15cm.
Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cere Terminated |
MAL | None listed |
| Aug 18, 2014 | Vascutek, Ltd. Gelweave (TM) Vascular Prostheses
Manufactured by - VASCUTEK Ltd
a TERUMO company Terminated |
DSY | None listed |