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    K Number
    K142461
    Device Name
    VASCU-GUARD Peripheral Vascular Patch
    Manufacturer
    Synovis Life Technologies Inc.
    Date Cleared
    2014-11-25

    (84 days)

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

    Synovis Life Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
    Device Description
    VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
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