Data / Medical devices / United Kingdom / Vascutek Ltd.
Vascutek Ltd.: FDA-registered device maker in Inchinnan Renfrewshire, United Kingdom, 16 510(k) clearances and 2 PMA approvals
Vascutek Ltd. is registered with the FDA (registration 9612515) in Inchinnan Renfrewshire, United Kingdom. It lists 7 device types. The FDA files 16 510(k) clearances and 2 PMA approvals under its listings, the newest dated February 27, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612515
- FEI number
- 3002808437
- Address
- Newmains Avenue, Inchinnan Renfrewshire, United Kingdom, PA4 9RR
- Owner or operator
- VASCUTEK LTD. (10039218)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- December 18, 2011
- Registered through
- 2026
- Brand names listed
- Cardiovascular fabric:Gelseal patch, Gelsoft patch, thinwall carotid patch, Gelseal Vascular Grafts, Gelsoft ERS Vascular Graft, Gelsoft Plus ERS, Gelsoft Plus ERS Vascular Grafts, Gelsoft Plus Vascular Graft, Gelsoft vascular graft, Gelsoft Plus Vascular Prostheses and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Graft, Vascular, Synthetic/Biologic Composite | MAL | 2 | Manufacturer | accessdata.fda.gov |
| Heart-Valve, Mechanical | LWQ | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
| Hybrid Stent Graft, Thoracic Aortic Lesion Treatment | QSK | 3 | Manufacturer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | 2 | Manufacturer | accessdata.fda.gov |
| Ventricular (Assist) Bypass | DSQ | 3 | Contract manufacturer, Contract sterilizer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2025 | K241550 | Gelweave Vascular Prostheses | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| November 15, 2024 | K241070 | Gelsoft Plus Vascular Prostheses | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| April 6, 2021 | K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| July 8, 2020 | K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | DXZ | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| July 14, 2017 | K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| June 30, 2017 | K162794 | Gelweave Vascular Grafts | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| January 7, 2010 | K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| June 19, 2009 | K090987 | VASCUTEK BRANCHED GELWEAVE | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| February 7, 2006 | K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| February 19, 2004 | K034010 | GELSOFT PLUS ERS | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| June 13, 2002 | K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS | DSY | Substantially Equivalent | Sulzer Carbomedics, Inc. | accessdata.fda.gov |
| January 25, 2001 | K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS | DSY | Substantially Equivalent | Sulzer Carbomedics, Inc. | accessdata.fda.gov |
| December 9, 1999 | K990503 | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS | DSY | Substantially Equivalent | Sulzermedica | accessdata.fda.gov |
| February 19, 1997 | K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | DSY | Substantially Equivalent - Subject to Tracking Reg. | Carbomedics, Inc. | accessdata.fda.gov |
| November 21, 1996 | K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH | DXZ | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| February 9, 1996 | K955230 | VASCUTEK GELSOFT PLUS VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | Vascutek, Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 19, 2022 | P210006 | Thoraflex Hybrid | QSK | 18 | September 8, 2026 | accessdata.fda.gov |
| January 11, 1993 | P890045 | GELSEAL TM TRIAXIAL VASCULAR GRAFT | MAL | 4 | July 5, 1995 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 18, 2025 | 98338 | Class II | Ongoing | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, | Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging. | accessdata.fda.gov |
| July 8, 2021 | 88278 | Class II | Terminated | 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 grafts: (1) Vascutek Terum | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. | accessdata.fda.gov |
| May 15, 2015 | 71305 | Class II | Terminated | 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 cerebral vasculature, and | Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. | accessdata.fda.gov |
| July 15, 2014 | 68952 | Class II | Terminated | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company | The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively). | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- All makers of Heart-Valve, Mechanical
- All makers of Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
- All makers of Heart-Valve, Non-Allograft Tissue
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- All makers of Graft, Vascular, Synthetic/Biologic Composite
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.