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510(k) Data Aggregation
K Number
DEN230002Device Name
DuraGraft
Manufacturer
Date Cleared
2023-10-04
(274 days)
Regulation Number
876.4100Why 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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