Optima Coil System (OptiBlock Line Extension)

Optima Coil System (OptiBlock Line Extension) is an FDA 510(k)-cleared medical device (K242582) manufactured by Balt USA, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 2024. Regulation: 8.