Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103812
    Device Name
    MITRA-LIFT
    Manufacturer
    Date Cleared
    2011-05-18

    (140 days)

    Product Code
    Regulation Number
    870.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCIENCITY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mitra-Lift is indicated as reinforcement for repair of the human cardiac mitral and tricuspid valves damaged by acquired or congenital disease, or as a replacement for a previously implanted annuloplasty ring. The annuloplasty ring should be used only in cases where visual inspection confirms that the valve is repairable and does not require replacement.
    Device Description
    Mitra-Lift Set is set of devices for mitral annuloplasty. This set consists of Mitra-Lift (implant device for mitral annuloplasty), and its accessories (Sizers and holders). The main device (Mitra-Lift series) is supplied sterile and intended for single use only. Mitra-Lift series is constructed of polyester textile materials and provided as the various sizes. It is intended to be used with its accessories, Mitral Sizer and Holder Handle.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1