510(k) K032884

FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH by Boston Scientific Epi — Product Code NFA

K032884 is an FDA 510(k) premarket notification submitted by Boston Scientific Epi for the device "FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH". The FDA issued a decision of Substantially Equivalent on August 6, 2004. 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.