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