SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE

SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE is an FDA 510(k)-cleared medical device (K921638) 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 February 9, 1993. Regulation: 8.