INTRA-AORTIC BALLOON SYSTEM

INTRA-AORTIC BALLOON SYSTEM is an FDA 510(k)-cleared medical device (K823739) manufactured by Smec, 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 February 17, 1983. Regulation: 8.