510(k) K122612

HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX by Maquet Cardiovascular, LLC — Product Code MAL

K122612 is an FDA 510(k) premarket notification submitted by Maquet Cardiovascular, LLC for the device "HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX". The FDA issued a decision of Substantially Equivalent on September 10, 2012. The device falls under product code MAL (Graft, Vascular, Synthetic/Biologic Composite), a Class II device regulated under 21 CFR 870.3450. Maquet Cardiovascular, LLC has at least 10 other 510(k) clearances on record.