BEUDAMED
    Product Code: PNQ FDA class 2 21 CFR 870.4510

    Apical Closure Device

    Cardiovascular

    The Apical Closure Device (product code PNQ) is a Class 2 cardiovascular device intended for closure of cardiac apical tissue, regulated under 870.4510. It requires 510(k) clearance and is flagged as an implant device due to its use in cardiac tissue closure. The device is not designated as life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PNQ
    Device Class
    FDA class 2
    Regulation Number
    870.4510
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    This device is intended for closure of cardiac apical tissue.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN150029 Permaseal