510(k) K210089

CATSmart, Automated Blood Processing Autotransfusion System by Fresenius Kabi AG — Product Code CAC

K210089 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "CATSmart, Automated Blood Processing Autotransfusion System". The FDA issued a decision of Substantially Equivalent on February 11, 2021. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.