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510(k) Data Aggregation

    K Number
    K112683
    Device Name
    SMI CARDIOVASCULAR PACH
    Manufacturer
    SOLIMAS MEDICAL, INC.
    Date Cleared
    2011-12-14

    (90 days)

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

    SOLIMAS 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 designed for cardiovascular patching. The SMI Cardiovascular Patch is comprised of a knitted polyethylene terephthalate (polyester) fabric covered silicone sheet reinforced with a thin sheet of polyester embedded in the silicone and optionally with a thin nickel-titanium (nitinol) alloy mesh. It is provided in various sizes and as flat and curved sheets.
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