510(k) K061332

FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) by Boston Scientific Corp — Product Code NFA

K061332 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)". The FDA issued a decision of Substantially Equivalent on August 11, 2006. The device falls under product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corp has at least 10 other 510(k) clearances on record.