Cardiopulmonary bypass intracardiac suction control.

21 C.F.R. § 870.4430
in effectEffective: 2024-07-01
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(a) Identification. A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

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