510(k) K183547

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter by Medtronic — Product Code DRF

K183547 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter". The FDA issued a decision of Substantially Equivalent on Jul 30, 2019. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Medtronic has 247 other 510(k) clearances on record.