AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 is an FDA 510(k)-cleared medical device (K132083) 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 October 27, 2013. Regulation: 8.