AtriCure cryoICE BOX (ACM)

AtriCure cryoICE BOX (ACM) is an FDA 510(k)-cleared medical device (K243157) manufactured by AtriCure, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2024. Regulation: 8.