SCEPTER C OCCLUSION BALLOON CATHETER

SCEPTER C OCCLUSION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K121785) 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 August 9, 2012. Regulation: 8.