# PFV · System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

_ ·  · Class 3_

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

## Overview

- **Product Code:** PFV
- **Device Name:** System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240023](https://fda.innolitics.com/submissions/CV/CV-misc/PFV/P240023.md) | WRAPSODY® Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Dec 19, 2024 | APPR |
| [P170042](https://fda.innolitics.com/submissions/CV/CV-misc/PFV/P170042.md) | Covera™ Vascular Covered Stent | C.R. Bard, Inc. | Jul 30, 2018 | APPR |
| [P130029](https://fda.innolitics.com/submissions/CV/CV-misc/PFV/P130029.md) | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | Bard Peripheral Vascular, Inc. | Jun 17, 2014 | APPR |
| [P130006](https://fda.innolitics.com/submissions/CV/CV-misc/PFV/P130006.md) | GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE | W. L. Gore & Associates, Inc. | Dec 5, 2013 | APPR |
| [P060002](https://fda.innolitics.com/submissions/CV/CV-misc/PFV/P060002.md) | FLAIR ENDOVASCULAR STENT GRAFT | Bard Peripheral Vascular | Jul 23, 2007 | APWD |

## Top Applicants

- Bard Peripheral Vascular — 1 clearance
- Bard Peripheral Vascular, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
- Merit Medical Systems, Inc. — 1 clearance
- W. L. Gore & Associates, Inc. — 1 clearance

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

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