ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter is an FDA 510(k)-cleared medical device (K212959) manufactured by Siemens Medical Solutions USA, 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 October 14, 2021. Regulation: 8.