BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    COPILOT BBC Valve

    Reg #: 3004091615 · FEI: 3004091615 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Vascular Netherlands
    Registration Number
    3004091615
    FEI Number
    3004091615
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Argonstraat 1
    City
    Heerlen Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K991102

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    US Agent

    Business Name
    Abbott Vascular
    Contact Name
    Keith Krohn
    Address
    26531 Ynez Road, M/S TCC-215
    City
    Temecula
    State
    CA
    ZIP
    92591
    Country
    US
    Email
    [email protected]
    Phone
    951 9143324

    Products

    Device Name Product Code
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL

    Proprietary Names

    COPILOT BBC Valve Guide Wire Accessory Kit with Copilot 20/30 PPAK w/COPILOT

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device