Regulatory Text
21 C.F.R. § 870.4290 — Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting. (a) Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. (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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21 C.F.R. § 870.4290
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The regulatory text of 21 C.F.R. § 870.4290 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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