SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE is an FDA 510(k)-cleared medical device (K070225) manufactured by Abiomed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2007. Regulation: 8.