BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile

    Reg #: 2184009 · FEI: 1000116158 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTRONIC PERFUSION SYSTEMS
    Registration Number
    2184009
    FEI Number
    1000116158
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7611 Northland Dr
    City
    Minneapolis
    State
    MN
    ZIP
    55428
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240190

    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
    Heat-Exchanger, Cardiopulmonary Bypass DTR
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile MYOtherm XP with Cortiva BioActive Surface, Non-Sterile MYOtherm XP with Cortiva BioActive Surface, Sterile Uncoated MYOtherm XP Cardioplegia Delivery Systems, Sterile

    Establishment Types

    Manufacture Medical Device