ENW · Catheter, Nasopharyngeal
Ear, Nose, Throat · 21 CFR 874.4175 · Class 1
Overview
| Product Code | ENW |
|---|---|
| Device Name | Catheter, Nasopharyngeal |
| 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | American V. Mueller | Jul 22, 1985 | SESE |
| K832476 | SILICONE SOFT-PAK EPISTAXIS CATHETER | Axiom Medical, Inc. | Nov 3, 1983 | SESE |
Top Applicants
- Axiom Medical, Inc. — 1 clearance
- American V. Mueller — 1 clearance
