← Product Code [EZN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN) · K953597

# NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER (K953597)

_Meadox Medicals, Div. Boston Scientific Corp. · EZN · Oct 7, 1995 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K953597

## Device Facts

- **Applicant:** Meadox Medicals, Div. Boston Scientific Corp.
- **Product Code:** [EZN](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN.md)
- **Decision Date:** Oct 7, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.5470
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K953597](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZN/K953597)

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