§ 874.4175. Nasopharyngeal catheter.
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/us/cfr/t21/s§ 874.4175·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001]