PLEUR-EVAC II AUTOTRANSFUSION SYSTEM

PLEUR-EVAC II AUTOTRANSFUSION SYSTEM is an FDA 510(k)-cleared medical device (K854301) manufactured by Deknatel, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 1985. Regulation: 8.