510(k) K040812

DETECT SURGICAL PACING AND MAPPING TOOL by Medtronic Vascular — Product Code LDF

K040812 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "DETECT SURGICAL PACING AND MAPPING TOOL". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Medtronic Vascular has at least 10 other 510(k) clearances on record.