Assert-IQ™ Insertable Cardiac Monitor

Assert-IQ™ Insertable Cardiac Monitor is an FDA 510(k)-cleared medical device (K230286) manufactured by ABBOTT MEDICAL. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2023. Regulation: 8.