510(k) K052302

HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION by Boston Scientific Corp — Product Code MAL

K052302 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION". The FDA issued a decision of Substantially Equivalent on September 12, 2005. 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.