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. [45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]