BEUDAMED
    Product Code: OKR FDA class 3 21 CFR 870.3545

    Ventricular Bypass (Assist) Device

    Cardiovascular

    The Ventricular Bypass (Assist) Device (product code OKR) is a Class 3 cardiovascular device regulated under 21 CFR 870.3545, requiring Premarket Approval (PMA) given its high-risk nature. The device assists the left or right ventricle in maintaining circulatory blood flow for periods under six hours and is either totally or partially implanted in the body. Despite being implanted, the implant flag is not set in the database; the device is reviewed by the Cardiovascular (CV) panel.

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    Basic Information

    Product Code
    OKR
    Device Class
    FDA class 3
    Regulation Number
    870.3545
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

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

    Definition

    A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.