KBI · Bougie, Eustachian
Ear, Nose, Throat · 21 CFR 874.4175 · Class 1
Overview
| Product Code | KBI |
|---|---|
| Device Name | Bougie, Eustachian |
| Regulation | 21 CFR 874.4175 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770959 | BOUGIE, FILIFORM, JACKSON | V. Mueller O.V. Baxter Healthcare Corp. | Jun 14, 1977 | SESE |
Top Applicants
- V. Mueller O.V. Baxter Healthcare Corp. — 1 clearance
