BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

    Reg #: 1124841 · FEI: 3000204839 · 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
    1124841
    FEI Number
    3000204839
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    125 BLUE BALL RD
    City
    ELKTON
    State
    MD
    ZIP
    21921
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130333

    Owner / Operator

    Firm Name
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Operator Number
    1828100
    Address
    6200 Jackson Road, --
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa G Hessabi

    Products

    Device Name Product Code
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR

    Establishment Types

    Manufacture Medical Device