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 Inari Medical, Inc., Sorin Group Italia S.R.L. and Inari Medical.
List of Apparatus, Autotransfusion devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Apparatus, Autotransfusion devices (product code CAC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →