BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo

    Reg #: 2184009 · FEI: 1000116158 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    1

    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
    K183490

    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
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface Affinity NT™ Oxygenator with Cortiva™ BioActive Surface Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface Affinity NT™ Oxygenator Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device