EMBOLD Fibered Detachable Coil System

EMBOLD Fibered Detachable Coil System is an FDA 510(k)-cleared medical device (K213398) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2022. Regulation: 8.