MODIFICATIONS TO INTRA-AORTIC BALLOONS

MODIFICATIONS TO INTRA-AORTIC BALLOONS is an FDA 510(k)-cleared medical device (K932268) 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 December 14, 1993. Regulation: 8.