510(k) K191880

Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter by Innovative Health, LLC — Product Code DRF

K191880 is an FDA 510(k) premarket notification submitted by Innovative Health, LLC for the device "Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter". The FDA issued a decision of Substantially Equivalent on December 11, 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. Innovative Health, LLC has at least 10 other 510(k) clearances on record.