AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES is an FDA 510(k)-cleared medical device (K060309) manufactured by Arrow Intl., 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 April 5, 2006. Regulation: 8.