AcQMap 3D Imaging and Mapping Catheter, Model 900009

AcQMap 3D Imaging and Mapping Catheter, Model 900009 is an FDA 510(k)-cleared medical device (K210766) manufactured by Acutus Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2022. Regulation: 8.