510(k) K052523

PROXIS SYSTEM by Velocimed, Inc. — Product Code NFA

K052523 is an FDA 510(k) premarket notification submitted by Velocimed, Inc. for the device "PROXIS SYSTEM". The FDA issued a decision of Substantially Equivalent on September 7, 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. Velocimed, Inc. has at least 5 other 510(k) clearances on record.