BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    VASCUTEK LTD.

    Reg #: 9612515 · FEI: 3002808437 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    VASCUTEK LTD.
    Registration Number
    9612515
    FEI Number
    3002808437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Newmains Avenue
    City
    Inchinnan Renfrewshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K963611
    PMA Number
    P890045

    Owner / Operator

    Firm Name
    VASCUTEK LTD.
    Operator Number
    10039218
    Address
    NEWMAINS AVE.
    City
    INCHINNAN
    State
    Renfrewshire
    Postal Code
    PA4 9RR
    Country
    GB

    Products

    Device Name Product Code
    Heart-Valve, Mechanical LWQ
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene DXZ
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY
    Graft, Vascular, Synthetic/Biologic Composite MAL
    Ventricular (Assist) Bypass DSQ
    Heart-Valve, Non-Allograft Tissue LWR
    Hybrid Stent Graft, Thoracic Aortic Lesion Treatment QSK

    Proprietary Names

    Cardiovascular fabric:Gelseal patch, Gelsoft patch, thinwall carotid patch Gelsoft Plus ERS Gelseal Vascular Grafts Gelsoft Plus Vascular Graft Gelweave Valsalva Gelweave Siena collared ante-flo and plexus with radiopaque markers Gelweave vascular grafts Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Prosthesis, vascular graft, of 6mm and greater diameter. Device name- Gelweave Vascular Grafts Gelweave™ Vascular Prostheses Gelsoft vascular graft Gelweave branched grafts and Siena grafts with and without radiopaque markers Gelsoft Plus ERS Vascular Grafts Gelsoft™ Plus Vascular Prostheses Gelweave branched vascular grafts with radiopaque markers Thoraflex Hybrid Gelsoft ERS Vascular Graft

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device