BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ProPlege Peripheral Retrograde Cardioplegia Device

    Reg #: 3031571797 · FEI: 3031571797 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENABLECV INC.
    Registration Number
    3031571797
    FEI Number
    3031571797
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6967 S River Gate Dr. Ste 104
    City
    Midvale
    State
    UT
    ZIP
    84047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120780

    Owner / Operator

    Firm Name
    enableCV Inc.
    Operator Number
    10092279
    Address
    6967 S River Gate Dr. Ste 104
    City
    Midvale
    State
    UT
    Postal Code
    84047
    Country
    US
    Correspondent
    Peter L Lindwall

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF

    Proprietary Names

    ProPlege Peripheral Retrograde Cardioplegia Device

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility