AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05 is an FDA 510(k)-cleared medical device (K091007) manufactured by Sorin Group Deutschland GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2009. Regulation: 8.