← Product Code [KNQ](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ) · K961438

# BALLON DILATATION CATHETER (K961438)

_Boston Scientific Corp · KNQ · Jul 31, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K961438

## Device Facts

- **Applicant:** Boston Scientific Corp
- **Product Code:** [KNQ](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ.md)
- **Decision Date:** Jul 31, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5365
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K961438](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNQ/K961438)

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