INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION is an FDA 510(k)-cleared medical device (K940231) 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 September 12, 1994. Regulation: 8.