View all text of Subpart J [§ 864.9050 - § 864.9875]
§ 864.9125 - Vacuum-assisted blood collection system.
(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
(b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.