PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON

PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K911000) 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 24, 1993. Regulation: 8.