BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Roller Pump for the Terumo Advanced Perfusion System 1

    Reg #: 1828100 · FEI: 1828100 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Registration Number
    1828100
    FEI Number
    1828100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6200 Jackson Road
    City
    ANN ARBOR
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162843

    Owner / Operator

    Firm Name
    Terumo Cardiovascular Systems Corp.
    Operator Number
    10039199
    Address
    6200 Jackson Road
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa Hessabi

    Products

    Device Name Product Code
    Pump, Blood, Cardiopulmonary Bypass, Roller Type DWB

    Proprietary Names

    Roller Pump for the Terumo Advanced Perfusion System 1

    Establishment Types

    Manufacture Medical Device