# NIO · Stent, Iliac

_ ·  · Class 3_

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

## Overview

- **Product Code:** NIO
- **Device Name:** Stent, Iliac
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P140030](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P140030.md) | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM | Biotronik, Inc. | Dec 17, 2015 | APPR |
| [P110043](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P110043.md) | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM | Abbott Vascular-Cardiac Therapies | Jul 31, 2012 | APPR |
| [P110035](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P110035.md) | EPIC SELF-EXPANDING NITINOL STENT SYSTEM | Boston Scientific Corp | Apr 13, 2012 | APPR |
| [P110028](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P110028.md) | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | Abbott Vascular, Inc. | Feb 22, 2012 | APPR |
| [P110011](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P110011.md) | ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM | Medtronic, Ireland | Oct 26, 2011 | APWD |
| [P090006](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P090006.md) | COMPLETE SE VASCULAR STENT SYSTEM | Medtronic Vascular | Mar 17, 2010 | APWD |
| [P090003](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P090003.md) | EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM | Boston Scientific Corporation | Mar 5, 2010 | APPR |
| [P080007](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P080007.md) | BARD E-LUMINEXX VASCULAR STENT | Bard Peripheral Vascular, Inc. | Dec 4, 2008 | APPR |
| [P050017](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P050017.md) | ZILVER VASCULAR STENT | Cook Ireland, Ltd. | Jun 26, 2006 | APPR |
| [P030045](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P030045.md) | INTRASTENT DOUBLESTRUT STENT | Medtronic Vascular, Inc. | Jun 8, 2004 | APPR |
| [P020036](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P020036.md) | S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM | Cordis US Corporation | Aug 12, 2003 | APPR |
| [P940019](https://fda.innolitics.com/submissions/CV/CV-misc/NIO/P940019.md) | WALLSTENT(R) ILIAC ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | May 28, 1996 | APPR |

## Top Applicants

- Abbott Vascular, Inc. — 1 clearance
- Abbott Vascular-Cardiac Therapies — 1 clearance
- Bard Peripheral Vascular, Inc. — 1 clearance
- Biotronik, Inc. — 1 clearance
- Boston Scientific Corp — 1 clearance

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

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