510(k) K023691

BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC by Boston Scientific Epi — Product Code NFA

K023691 is an FDA 510(k) premarket notification submitted by Boston Scientific Epi for the device "BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC". The FDA issued a decision of Substantially Equivalent on June 4, 2003. 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 Epi has at least 1 other 510(k) clearance on record.