BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Gelsoft Plus Vascular Graft

    Reg #: 9612515 · FEI: 3002808437 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VASCUTEK LTD.
    Registration Number
    9612515
    FEI Number
    3002808437
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Newmains Avenue
    City
    Inchinnan Renfrewshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K955230

    Owner / Operator

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

    US Agent

    Business Name
    Bolton Medical Inc
    Contact Name
    Megan Indeglia
    Address
    799 INTERNATIONAL PARKWAY
    City
    Sunrise
    State
    FL
    ZIP
    33325
    Country
    US
    Email
    [email protected]
    Phone
    954 6265122

    Products

    Device Name Product Code
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter DSY

    Proprietary Names

    Gelsoft Plus Vascular Graft

    Establishment Types

    Manufacture Medical Device