Retracta Detachable Embolization Coil

Retracta Detachable Embolization Coil is an FDA 510(k)-cleared medical device (K151676) manufactured by Cook Incorporated. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2015. Regulation: 8.