BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Abbott Vascular

    Reg #: 3009564766 · FEI: 3009564766 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    Abbott Vascular
    Registration Number
    3009564766
    FEI Number
    3009564766
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    52 Calle 3, B31 Coyol Free Zone
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K180040

    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
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Catheter, Percutaneous DQY
    Transducer, Pressure, Catheter Tip DXO
    Wire, Guide, Catheter DQX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    Trek RX; Mini Trek RX (1.50-20 Global); Mini Trek RX (1.20 LTD IND); NC TREK OTW CORONARY DILATATION CATHETER Armada 35 and 35LL Dilatation Catheters PressureWire X NC TREK RX CORONARY DILATATION CATHETER Trek RX Trek OTW Mini Trek II OTW (1.20 LTD IND Mini Trek OTW Dilatation Catheters Mini Trek RX Mini Trek II OTW (1.50-20) Armada14 XT Dilatation Catheter NC TREK NEO NC TREK RX Coronary Dilatation Catheter Mini Trek OTW Mini Trek II OTW

    Establishment Types

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