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510(k) Data Aggregation

    K Number
    K182493
    Device Name
    Bovine Pericardial Tissue Patch
    Manufacturer
    Date Cleared
    2019-06-18

    (280 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tisgenx

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tisgenx's Bovine Pericardial Tissue Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line during general surgical procedures.
    Device Description
    The Tisqenx Bovine Pericardial Tissue Patch is a bovine pericardium that is chemically crosslinked using a glutaraldehyde solution to impart stability. The device is provided terminally sterile, packaged in a sterile barrier jar filed with a liquid chemical sterilant. The device is intended for single patient use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency reconstruction and repair, and reinforcing the suture line during general surgical procedures.
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