510(k) K152784

Pacel Bipolar Pacing Catheters by St Jude Medical — Product Code LDF

K152784 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "Pacel Bipolar Pacing Catheters". The FDA issued a decision of Substantially Equivalent on October 22, 2015. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. St Jude Medical has at least 10 other 510(k) clearances on record.