510(k) K210766

AcQMap 3D Imaging and Mapping Catheter, Model 900009 by Acutus Medical, Inc. — Product Code MTD

K210766 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQMap 3D Imaging and Mapping Catheter, Model 900009". The FDA issued a decision of Substantially Equivalent on June 21, 2022. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Acutus Medical, Inc. has at least 10 other 510(k) clearances on record.