BALADI INVERTER WITH COAXIAL AORTIC PUNCH

BALADI INVERTER WITH COAXIAL AORTIC PUNCH is an FDA 510(k)-cleared medical device (K980128) manufactured by Cardio Medical Solutions, 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 July 23, 1998. Regulation: 8.