← Product Code [ENW](/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW) · K832476

# SILICONE SOFT-PAK EPISTAXIS CATHETER (K832476)

_Axiom Medical, Inc. · ENW · Nov 3, 1983 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW/K832476

## Device Facts

- **Applicant:** Axiom Medical, Inc.
- **Product Code:** [ENW](/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW.md)
- **Decision Date:** Nov 3, 1983
- **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/ENW/K832476](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ENW/K832476)

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