# PRC · Drug-Coated Peripheral Transluminal Angioplasty Catheter

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/PRC

## Overview

- **Product Code:** PRC
- **Device Name:** Drug-Coated Peripheral Transluminal Angioplasty Catheter
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P190008](https://fda.innolitics.com/submissions/CV/CV-misc/PRC/P190008.md) | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | Nov 21, 2019 | APPR |
| [P170003](https://fda.innolitics.com/submissions/CV/CV-misc/PRC/P170003.md) | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 | Lutonix | Aug 25, 2017 | APPR |

## Top Applicants

- Lutonix — 1 clearance
- Medtronic Vascular, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/PRC](https://fda.innolitics.com/submissions/CV/CV-misc/PRC)

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