510(k) K023878

GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM by Medtronic Vascular — Product Code NFA

K023878 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 24, 2003. 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. Medtronic Vascular has at least 10 other 510(k) clearances on record.