BEUDAMED
    Product Code: QQK FDA class 3

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    Unknown

    The Normothermic Machine Perfusion System for the Preservation of Donor Livers Prior to Transplantation is a device intended for machine preservation of donor livers at near-physiological temperature prior to transplantation, helping to maintain organ viability and assess organ function before transplant. This device is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA), and is designated as life-sustaining. No regulation number is assigned; it is reviewed by the Gastroenterology and Urology panel. Product code QQK. The device is not an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QQK
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is intended for machine preservation of donor livers prior to transplantation.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.