FDA Product Code CAC: Apparatus, Autotransfusion

Recovering the patient's own shed blood reduces transfusion requirements during surgery. FDA product code CAC covers autotransfusion apparatus used in operative and post-operative blood recovery.

These systems collect, filter, wash, and reinfuse the patient's own shed blood during cardiac, vascular, and orthopedic surgery. Autotransfusion reduces allogeneic blood exposure and its associated risks, including transfusion reactions and infection transmission.

CAC devices are Class II medical devices, regulated under 21 CFR 868.5830 and reviewed by the FDA Hematology panel.

Leading manufacturers include Boehringer Laboratories, Deknatel, Inc. and Shiley, Inc..