View all text of Subpart E [§ 870.4075 - § 870.4885]
§ 870.4430 - Cardiopulmonary bypass intracardiac suction control.
(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.