SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)

SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) is an FDA 510(k)-cleared medical device (K965236) 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 June 30, 1997. Regulation: 8.