Optima Coil System

Optima Coil System is an FDA 510(k)-cleared medical device (K172390) manufactured by Blockade Medical, LLC (D.B.A. Balt Usa). This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 17, 2018. Regulation: 8.