AZUR PUSHABLE 18 & 35 SYSTEM

AZUR PUSHABLE 18 & 35 SYSTEM is an FDA 510(k)-cleared medical device (K130577) 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 June 16, 2013. Regulation: 8.