AZUR CX Detachable 35 Coils

AZUR CX Detachable 35 Coils is an FDA 510(k)-cleared medical device (K151358) manufactured by MicroVention, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2015. Regulation: 8.