510(k) K201445

MultiCath, AcQRate Dx Fixed Curve Catheter by Biotronik, Inc. — Product Code DRF

K201445 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "MultiCath, AcQRate Dx Fixed Curve Catheter". The FDA issued a decision of Substantially Equivalent on September 2, 2021. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Biotronik, Inc. has at least 10 other 510(k) clearances on record.