21 CFR 874.4175 — Catheter, Nasopharyngeal
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4175
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ENW | Catheter, Nasopharyngeal | 1 | 2 | |
| KBI | Bougie, Eustachian | 1 | 1 | |
| KBY | Set, Filliform, Eustachian | 1 | 0 |
