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510(k) Data Aggregation

    K Number
    DEN230002
    Device Name
    DuraGraft
    Manufacturer
    Date Cleared
    2023-10-04

    (274 days)

    Product Code
    Regulation Number
    876.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Marizyme, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
    Device Description
    DuraGraft Vascular Conduit Solution is a clear, colorless to slightly yellow, aseptically processed, non-pyrogenic solution for room temperature flushing and storage of vascular conduits used during the harvesting and grafting interval in Coronary Artery Bypass Grafting (CABG) surgeries. DuraGraft Vascular Conduit Solution is supplied in two separate containers composed of a Solution A (237.5mL) and a Solution B (12.5-13.5mL). Solution A is mixed with 12.5mL of Solution B prior to use. DURAGRAFT Vascular Conduit Solution has an osmolality of about 305 mOsmol/kg, viscosity of 1.06 cST, a sodium concentration of 155-160 mEq/L, a potassium concentration of 5.8 mEq/L, and a pH of about 7.4 at room temperature.
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