CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE

CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE is an FDA 510(k)-cleared medical device (K963758) manufactured by Sorin Biomedical, 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 February 19, 1998. Regulation: 8.