BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott Medical

    Reg #: 3020950818 · FEI: 3020950818 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3020950818
    FEI Number
    3020950818
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1820 Bastian Court
    City
    Westfield
    State
    IN
    ZIP
    46074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190167
    PMA Number
    P100009

    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

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Catheter, Steerable DRA
    Mitral Valve Repair Devices NKM

    Proprietary Names

    MitraClip™ G5 Steerable Guide Catheter CPS Direct PL CPS Direct PL VBT Renal Guide Catheter MitraClip Steerable Guide Catheter TriClip™ G5 Steerable Guide Catheter MitraClip G4 Steerable Guide Catheter TriClip Steerable Guide Catheter Steerable Guide Catheter MitraClip NTR Clip Delivery System MitraClip G4 Clip Delivery System MitraClip XTR Clip Delivery System MitraClip™ G5 Delivery System MitraClip Clip Delivery System MitraClip G4 System MitraClip™ G5 Delivery system

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device