21 C.F.R. § 870.4430

Current through October 31, 2024
Section 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 .

21 C.F.R. §870.4430

45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812 , Dec. 30, 2019