510(k) K021213

MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS by Boston Scientific Corp — Product Code MAL

K021213 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS". The FDA issued a decision of Substantially Equivalent on April 19, 2002. The device falls under product code MAL (Graft, Vascular, Synthetic/Biologic Composite), a Class II device regulated under 21 CFR 870.3450. Boston Scientific Corp has at least 10 other 510(k) clearances on record.