Axium Detachable Coil; Axium Prime Detachable Coil

Axium Detachable Coil; Axium Prime Detachable Coil is an FDA 510(k)-cleared medical device (K233420) manufactured by Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2023. Regulation: 8.