Axium Prime Detachable Coil System

Axium Prime Detachable Coil System is an FDA 510(k)-cleared medical device (K162704) 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 January 2, 2017. Regulation: 8.