BEUDAMED
    Product Code: OJE

    Right Ventricular Bypass (Assist) Device

    Unknown

    The Right Ventricular Bypass (Assist) Device is a cardiovascular device intended to provide circulatory support for patients experiencing cardiogenic shock due to acute right ventricular failure, temporarily taking over the pumping function of the right ventricle. It carries a device class designation of "f," indicating it is regulated under a Humanitarian Device Exemption (HDE) pathway for rare conditions, reviewed by the Cardiovascular panel; no regulation number has been assigned. The product code is OJE. It is not flagged as an implant or life-sustaining device in the classification record.

    View on FDA
    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OJE
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    6

    Device Characteristics

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

    Definition

    To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.