BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TandemHeart Controller

    Reg #: 2133810 · FEI: 3000203066 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MINNETRONIX, INC.
    Registration Number
    2133810
    FEI Number
    3000203066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1635 ENERGY PARK DR.
    City
    Saint Paul
    State
    MN
    ZIP
    55108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061369

    Owner / Operator

    Firm Name
    Minnetronix Medical, Inc.
    Operator Number
    9033484
    Address
    1635 ENERGY PARK DR., --
    City
    Saint Paul
    State
    MN
    Postal Code
    55108
    Country
    US
    Correspondent
    Mary Stietz

    Products

    Device Name Product Code
    Control, Pump Speed, Cardiopulmonary Bypass DWA

    Proprietary Names

    TandemHeart Controller

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)