510(k) K053195

SPIDERX EMBOLIC PROTECTION DEVICE by Ev3, Inc. — Product Code NFA

K053195 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "SPIDERX EMBOLIC PROTECTION DEVICE". The FDA issued a decision of Substantially Equivalent on June 23, 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. Ev3, Inc. has at least 10 other 510(k) clearances on record.