510(k) K073563

MODIFICATION TO PROXIS SYSTEM by St Jude Medical — Product Code NFA

K073563 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "MODIFICATION TO PROXIS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 2008. 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.