DATASCOPE MODEL 83 IABP SYSTEM

DATASCOPE MODEL 83 IABP SYSTEM is an FDA 510(k)-cleared medical device (K821951) 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 December 20, 1982. Regulation: 8.