21 CFR 874.4175
§ 874.4175 Nasopharyngeal catheter.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 874.4175, § 874.4175 Nasopharyngeal catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90236
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Full text
(a) Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.