21 C.F.R. § 868.5830Download PDFCurrent through November 30, 2024Section 868.5830 - Autotransfusion apparatus(a)Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)Classification. Class II (performance standards). 21 C.F.R. § 868.5830