BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vitalflow™ Console

    Reg #: 3011468686 · FEI: 3011468686 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MC3, Inc.
    Registration Number
    3011468686
    FEI Number
    3011468686
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2555 Bishop Circle West
    City
    Dexter
    State
    MI
    ZIP
    48130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230364

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Blood Pump For Ecmo, Long-Term (> 6 Hours) Use QNR

    Proprietary Names

    Vitalflow™ Console

    Establishment Types

    Manufacture Medical Device