BEUDAMED
    Product Code: SBK FDA class 2 21 CFR 870.3490

    Artificial Chordae Tendineae Surgical Replacement System

    Cardiovascular

    An artificial chordae tendineae surgical replacement system is a standalone prescription implant device consisting of nonabsorbable suture-based implants and suture placement devices used via open surgical approach under direct visualization to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency; it includes clips or fasteners to secure the suture but is not intended for transcatheter or percutaneous access. It is classified as FDA Class II (510(k) required) under regulation 870.3490 in the Cardiovascular specialty, with product code SBK. The device is flagged as both an implant and life-sustaining, reflecting its critical cardiac function.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    SBK
    Device Class
    FDA class 2
    Regulation Number
    870.3490
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

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

    Definition

    An artificial chordae tendineae surgical replacement system is a standalone, prescription device consisting of nonabsorbable suture-based implant and suture placement device(s) that is used to replace mitral or tricuspid chordae tendineae in patients with atrioventricular valve insufficiency. The device includes clips or fasteners to secure suture that are not embedded in the cardiac tissue. The system is used via surgical approach under direct visualization and not via transcatheter or percutaneous access.

    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
    DEN230069 Mi-CHORD System

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.