510(k) K051984

FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 by Boston Scientific Corp — Product Code NFA

K051984 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300". The FDA issued a decision of Substantially Equivalent on April 10, 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.