Title 21

SECTION 870.4420

870.4420 Cardiopulmonary bypass cardiotomy return sucker.

§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.

(a) Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.

(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]

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