§ 870.4430. Cardiopulmonary bypass intracardiac suction control.
68 words·~1 min read·
/us/cfr/t21/s§ 870.4430·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]