← Product Code [KBI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI) · K770959

# BOUGIE, FILIFORM, JACKSON (K770959)

_V. Mueller O.V. Baxter Healthcare Corp. · KBI · Jun 14, 1977 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI/K770959

## Device Facts

- **Applicant:** V. Mueller O.V. Baxter Healthcare Corp.
- **Product Code:** [KBI](/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI.md)
- **Decision Date:** Jun 14, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4175
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI/K770959](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/KBI/K770959)

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