21 C.F.R. · Food and Drugs
21 C.F.R. § 870.4420

Cardiopulmonary bypass cardiotomy return sucker.

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Regulatory Text

21 C.F.R. § 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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The regulatory text of 21 C.F.R. § 870.4420 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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