AcQMap 3D Imaging and Mapping Catheter

AcQMap 3D Imaging and Mapping Catheter is an FDA 510(k)-cleared medical device (K201341) 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 September 14, 2020. Regulation: 8.