Axium Detachable Coil; Axium Prime Detachable Coil

Axium Detachable Coil; Axium Prime Detachable Coil is an FDA 510(k)-cleared medical device (K203432) manufactured by Micro Therapeutics, Inc. 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 July 6, 2021. Regulation: 8.