510(k) K013913

PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM by Medtronic Percusurge, Inc. — Product Code NFA

K013913 is an FDA 510(k) premarket notification submitted by Medtronic Percusurge, Inc. for the device "PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2002. 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 Percusurge, Inc. has at least 1 other 510(k) clearance on record.