AXIUM DETACHABLE COIL SYSTEM

AXIUM DETACHABLE COIL SYSTEM is an FDA 510(k)-cleared medical device (K133310) 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 9, 2014. Regulation: 8.