510(k) K060651

PROXIS SYSTEM, MODEL EPS101 by St Jude Medical — Product Code NFA

K060651 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "PROXIS SYSTEM, MODEL EPS101". The FDA issued a decision of Substantially Equivalent on September 13, 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. St Jude Medical has at least 10 other 510(k) clearances on record.