8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K892799) manufactured by Kontron Instruments, 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 19, 1989. Regulation: 8.