Vacuum-assisted blood collection system.

21 C.F.R. § 864.9125
in effectEffective: 2024-07-01
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(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.

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