DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL

DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL is an FDA 510(k)-cleared medical device (K903892) 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 October 18, 1990. Regulation: 8.