

# QRH · Catheter, Balloon, Urethral, Drug-Coated

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/QRH

## Overview

- **Product Code:** QRH
- **Device Name:** Catheter, Balloon, Urethral, Drug-Coated
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Dilate urethral strictures

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210020](/device/P210020.md) | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | Dec 3, 2021 | APPR |

## Top Applicants

- Urotronic, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QRH](https://fda.innolitics.com/productcode/QRH)

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