AC3 Series Intra-Aortic Balloon Pump (IABP)

AC3 Series Intra-Aortic Balloon Pump (IABP) is an FDA 510(k)-cleared medical device (K192238) manufactured by Arrow International, Teleflex. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 2019. Regulation: 8.