DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL

DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL is an FDA 510(k)-cleared medical device (K821065) 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 August 18, 1982. Regulation: 8.