BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MitraPatch Mitral Valve Repair System

    K Number: K252126 · Decision Dec 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    150

    Basic Information

    Device Name
    MitraPatch Mitral Valve Repair System
    K Number
    K252126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chawla Heart Technologies, LLC
    Date Received
    July 7, 2025
    Decision Date
    December 4, 2025
    Product Code
    PAW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PAW), ordered by most recent decision date.

    CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT

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