BEUDAMED
    FDA Registration Active 🇫🇷 France

    HYBRID Guidewire

    Reg #: 8023054 · FEI: 3004216185 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BALT EXTRUSION
    Registration Number
    8023054
    FEI Number
    3004216185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10 RUE DE LA CROIX VIGNERON
    City
    MONTMORENCY Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K182337

    Owner / Operator

    Firm Name
    BALT EXTRUSION
    Operator Number
    8023054
    Address
    10 RUE CROIX VIGNERON
    City
    MONTMORENCY
    State
    Val-d'Oise
    Postal Code
    95160
    Country
    FR
    Correspondent
    David Vu

    US Agent

    Business Name
    Balt USA, LLC
    Contact Name
    David Vu
    Address
    29 Parker
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 7881443

    Products

    Device Name Product Code
    Guide, Wire, Catheter, Neurovasculature MOF
    Wire, Guide, Catheter DQX

    Proprietary Names

    HYBRID Guidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)