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510(k) Data Aggregation

    K Number
    K041736
    Device Name
    PFA PATCH
    Manufacturer
    PERITEC BIOSCIENCES, LLC.
    Date Cleared
    2005-01-13

    (199 days)

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

    PERITEC BIOSCIENCES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PFA patch is designed for use in peripheral arteries as a patch following arterial endarterectomy and as a tissue pledget for arterial surgery. It also can be used as a buttress for over sewing suture lines. The PFA Patch is intended for peripheral vascular reconstruction of blood vessels and arteriovenous (A/V) revisions.
    Device Description
    The PFA Vascular Patch is a cross-linked piece of bovine peritoneal / fascia tissue and is available in the following sizes: 0.8 cm x 3.0 cm 1.0 cm x 8.0 cm 2.0 cm x 9.0 cm The device is packaged in an industry standard polymeric vial with a threaded cap sealed by a plastic shrink wrap. The tissue is packaged with a solution of glutaraldehyde. The sealed container is placed in a shelf carton with the Instructions for Use. The shelf carton contains a freeze warning indicator. The product is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.
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