510(k) K161249

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead by Medtronic — Product Code LDF

K161249 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Streamline 6495 Bipolar Temporary Myocardial Pacing Lead". The FDA issued a decision of Substantially Equivalent on August 19, 2016. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Medtronic has at least 10 other 510(k) clearances on record.