CARDIOSAVE Intra-Aortic Balloon Pump

CARDIOSAVE Intra-Aortic Balloon Pump is an FDA 510(k)-cleared medical device (K181122) 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 May 30, 2018. Regulation: 8.