ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP

ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP is an FDA 510(k)-cleared medical device (K002256) 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 May 2, 2001. Regulation: 8.