SAPPHIRE NXT DETACHABLE COIL SYSTEM

SAPPHIRE NXT DETACHABLE COIL SYSTEM is an FDA 510(k)-cleared medical device (K041649) manufactured by Micro Therapeutics, Inc.. 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 15, 2004. Regulation: 8.