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510(k) Data Aggregation

    K Number
    K240925
    Device Name
    DuraGraft Vascular Conduit Solution
    Manufacturer
    Date Cleared
    2024-05-01

    (27 days)

    Product Code
    Regulation Number
    876.4100
    Why did this record match?
    Product Code :

    QEJ

    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 single-use, clear, colorless to slightly yellow, non-pyrogenic solution used as a flushing and storage solution during the harvesting and grafting interval in Coronary Artery Bypass Grafting (CABG surgeries). All ingredients are Generally Recognized as Safe (GRAS) and comply with United States Pharmacopoeia (USP) or National Formulary (NF) specifications. No components are of animal or blood origin. The product is aseptically processed using aseptic filling procedures. Stability testing at 25℃ supports a shelf life of 2 years at a storage temperature of 20-25°C (controlled room temperature). The salts in DuraGraft are intended for buffering (to maintain both ionic balance and isotonicity with respect to vascular conduits. The organic components are intended to provide a non-oxidizing environment for vascular conduits and to maintain additional buffering capability and osmolality. The organic components are all normal constituents of blood and are included for their roles in maintaining the extracellular environment of vascular conduits to prevent ischemic injury. DuraGraft Vascular Conduit Solution is provided in two aseptically processed containers; Solution A and Solution B. Solution A is an aqueous based solution provided in sterile PETG bottles with white HDPE closures. Solution B is an aqueous based solution provided in sterile Type I borosilicate glass vials with bromobutyl rubber stoppers with aluminum crimps. Solution B are mixed at the point of use to generate DuraGraft Vascular Conduit Solution which is the graft storage and flushing solution. The mixed solution is used at room temperature and has an osmolality of about 305 Osmol/kg, viscosity of 1.06 cST, a sodium concentration of 155-160 mEq/L (sodium concentration is expressed as a range due to the use of Sodium bicarbonate for pH adjustment of Solution A and is based on review of several (10+) manufacturing batch records), and a potassium concentration of 5.8 mEq/L, and a pH of 7.4 at room temperature.
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    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?
    Product Code :

    QEJ

    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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