§864.9125. Vacuum-assisted blood collection system.
21 C.F.R. § 864.9125
Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]