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510(k) Data Aggregation

    K Number
    K192615
    Device Name
    Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
    Manufacturer
    Synovis Life Technologies, Inc. (Baxter International Inc.)
    Date Cleared
    2019-12-17

    (85 days)

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

    Synovis Life Technologies, Inc. (Baxter International Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.
    Device Description
    PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States. The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure. PSDV-SG is provided sterile and intended for single use. Sterilization occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.
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