BEUDAMED
    Product Code: MNJ FDA class 2 21 CFR 870.4400

    Valve, Pressure Relief, Cardiopulmonary Bypass

    Cardiovascular

    The Pressure Relief Valve for Cardiopulmonary Bypass is a cardiovascular device used during open-heart surgery to regulate and relieve excess pressure within the bypass circuit, protecting the patient and equipment from pressure surges. It is classified as FDA Class 2 under 21 CFR 870.4400, requiring 510(k) premarket notification. The product code is MNJ, reviewed by the Cardiovascular panel.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    5

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    Basic Information

    Product Code
    MNJ
    Device Class
    FDA class 2
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K992964 IBC VENT VALVE, MODEL 1400
    K941492 PRESSURE RELIEF VALVE