BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PTFE Coated Guidewire

    Reg #: 1221806 · FEI: 1221806 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GUIDEWIRE TECHNOLOGIES, INC.
    Registration Number
    1221806
    FEI Number
    1221806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    26 KEEWAYDIN DR.
    City
    SALEM
    State
    NH
    ZIP
    03079
    Country
    US

    Regulatory Submissions

    510(k) Number
    K902153

    Owner / Operator

    Firm Name
    GUIDEWIRE TECHNOLOGIES, INC.
    Operator Number
    1221806
    Address
    26 KEEWAYDIN DR., --
    City
    SALEM
    State
    NH
    Postal Code
    03079
    Country
    US
    Correspondent
    DOUGLAS J CURTIS

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    PTFE Coated Guidewire

    Establishment Types

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