Haemonetics Cell Saver Elite Autotransfusion System

Haemonetics Cell Saver Elite Autotransfusion System is an FDA 510(k)-cleared medical device (K160197) manufactured by Haemonetics Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2016. Regulation: 8.