BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TERUMO CARDIOVASCULAR SYSTEMS THI PLANT

    Reg #: 3005228872 · FEI: 3005228872 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    TERUMO CARDIOVASCULAR SYSTEMS THI PLANT
    Registration Number
    3005228872
    FEI Number
    3005228872
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6190 JACKSON ROAD
    City
    Ann Arbor
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250684

    Owner / Operator

    Firm Name
    TERUMO CARDIOVASCULAR SYSTEMS THI PLANT
    Operator Number
    9098362
    Address
    6190 Jackson Road, --
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa - Hessabi

    Products

    Device Name Product Code
    System, Imaging, Optical Coherence Tomography (Oct) NQQ
    Ventricular (Assist) Bypass DSQ

    Proprietary Names

    OPUSWAVE Dual Sensor Imaging System Ventricular bypass

    Establishment Types

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