Vascutek, Ltd.
Inchinnan Renfrewshire, GB
VASCUTEK LTD. appears in FDA device records in Inchinnan Renfrewshire, GB. FDA records list 26 510(k) clearances between and , 18 PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Vascutek, Ltd. between 1991 and 2025. The busiest year on record is 1991, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 4 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 4 |
| 2010 | 1 |
| 2017 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241550 | Gelweave™ Vascular Prostheses | DSY | Substantially Equivalent | |
| K241070 | Gelsoft™ Plus Vascular Prostheses | DSY | Substantially Equivalent | |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | DSY | Substantially Equivalent | |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | DXZ | Substantially Equivalent | |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | DSY | Substantially Equivalent | |
| K162794 | Gelweave Vascular Grafts | DSY | Substantially Equivalent | |
| K093817 | GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS | DSY | Substantially Equivalent | |
| K092863 | MAXIFLO, TAPERFLO | DSY | Substantially Equivalent | |
| K091778 | VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS | DSY | Substantially Equivalent | |
| K090987 | VASCUTEK BRANCHED GELWEAVE | DSY | Substantially Equivalent | |
| K081560 | VASCUTEK CANNULA GRAFT, MODEL CGS2008S | DWF | Substantially Equivalent | |
| K070323 | TEMPORARY LIMB SALVAGE SHUNT | DXC | Substantially Equivalent | |
| K060142 | VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS | DSY | Substantially Equivalent | |
| K043552 | VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES | DSY | Substantially Equivalent | |
| K041528 | MODIFICATION TO EPTFE GRAFT | DSY | Substantially Equivalent | |
| K040829 | GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR | DSY | Substantially Equivalent | |
| K034010 | GELSOFT PLUS ERS | DSY | Substantially Equivalent | |
| K030999 | EPTFE VASCULAR PROSTHESIS; SEALPTFE | DSY | Substantially Equivalent | |
| K964959 | VASCUTEK TWILLWEAVE VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K963611 | VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH | DXZ | Substantially Equivalent | |
| K955230 | VASCUTEK GELSOFT PLUS VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K952293 | VASCUTEK GELWEAVE VASCULAR GRAFT | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K910866 | VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K910865 | TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K910864 | EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS | DSY | Substantially Equivalent | |
| K910863 | EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS | DSY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9612515 | 3002808437 | VASCUTEK LTD. | Newmains Avenue, Inchinnan Renfrewshire PA4 9RR GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXCClamp, Vascular
- MALGraft, Vascular, Synthetic/Biologic Composite
- LWQHeart-Valve, Mechanical
- LWRHeart-Valve, Non-Allograft Tissue
- QSKHybrid Stent Graft, Thoracic Aortic Lesion Treatment
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DSQVentricular (Assist) Bypass
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1492-2026 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E, | 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. | Class II | Open, Classified | |
| Z-2543-2021 | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. | Class II | Terminated | |
| Z-2542-2021 | 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 Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm, Bifurcate 45cm, REF 631408, sterile. (2) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 16 x 8mm, Bifurcate 45cm, REF 631608, sterile. (3) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 18 x 9mm, Bifurcate 45 cm, REF 631809, sterile. (4) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 20 x 10mm, Bifurcate 45cm, REF 632010, sterile. (5) Vascutex Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 22 x 11mm, Bifurcate 45cm, REF 632211, sterile | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. | Class II | Terminated | |
| Z-1913-2015 | 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 cerebral vasculature, and to provide vascular access. | Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. | Class II | Terminated | |
| Z-1912-2015 | 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 to provide vascular access. | Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. | Class II | Terminated | |
| Z-2266-2014 | 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). | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain