ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter is an FDA 510(k)-cleared medical device (K173618) 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 December 18, 2017. Regulation: 8.