INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED is an FDA 510(k)-cleared medical device (K961509) 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 November 14, 1996. Regulation: 8.