FRENCH INTRA-AORTIC 9.5 BALLOON ON KON

FRENCH INTRA-AORTIC 9.5 BALLOON ON KON is an FDA 510(k)-cleared medical device (K831397) 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 1, 1983. Regulation: 8.