INTRA-AORTIC BALLOON, TYPE S

INTRA-AORTIC BALLOON, TYPE S is an FDA 510(k)-cleared medical device (K790775) manufactured by Datascope Corp.. 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 30, 1979. Regulation: 8.