PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON

PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K896497) 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 16, 1990. Regulation: 8.