BEUDAMED
    Product Code: DSQ FDA class 3

    Ventricular (Assist) Bypass

    Unknown

    The Ventricular (Assist) Bypass device is a cardiovascular mechanical circulatory support device implanted to assist a failing ventricle by pumping blood from the heart to the systemic or pulmonary circulation, providing hemodynamic support in patients with severe heart failure. It is classified as an FDA Class 3 device, the highest risk category, and requires Premarket Approval (PMA) before marketing. An approved PMA exists for this device type (P870072). This device is flagged as an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    DSQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    Approved pma: P870072

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.