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510(k) Data Aggregation

    K Number
    K122105
    Device Name
    SMI CARDIOVASCULAR PATCH
    Manufacturer
    SOLINAS MEDICAL INC
    Date Cleared
    2012-12-07

    (143 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLINAS MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Solinas Medical, Inc. SMI Cardiovascular Patch is indicated for cardiovascular patching.
    Device Description
    The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet and with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved shapes. The SMI Cardiovascular Patch in the flat configuration is 2 cm x 7.5 cm and the following curved sizes: 6, 7, 8, 9, and 10 mm diameters, 4.5 cm length, and 360° arc angle. A manufacturing change was also made to bond the polyester fabric to the silicone.
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