DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON

DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K910997) 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 4, 1991. Regulation: 8.