DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO is an FDA 510(k)-cleared medical device (K850482) 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 21, 1985. Regulation: 8.