

# NIP · Stent, Superficial Femoral Artery

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/NIP

## Overview

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

## Identification

Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P050017S024](/device/P050017S024.md) | Zilver Flex(R) 35 Vascular Stent | Cook Ireland, Ltd. | Jul 1, 2025 | APPR |
| [P180003](/device/P180003.md) | BioMimics 3D Vascular Stent System | Veryan Medical, Ltd. | Oct 4, 2018 | APPR |
| [P160025](/device/P160025.md) | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM | Biotronik AG | Mar 23, 2017 | APPR |
| [P160004](/device/P160004.md) | GORE TIGRIS VASCULAR STENT | W. L. Gore & Associates, Inc. | Jul 27, 2016 | APWD |
| [P070014S037](/device/P070014S037.md) | BARD LIFESTENT VASCULAR STENT SYSTEM | Bard Peripheral Vascular, Inc. | May 31, 2016 | APPR |
| [P140028](/device/P140028.md) | INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM | Boston Scientific Corporation | Jul 21, 2015 | APPR |
| [P140002](/device/P140002.md) | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM | Terumo Medical Corporation | May 22, 2015 | APPR |
| [P110023S007](/device/P110023S007.md) | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM | Medtronic Vascular, Inc. | Oct 10, 2014 | APPR |
| [P040037S060](/device/P040037S060.md) | GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE | W. L. Gore & Associates, Inc. | Sep 19, 2014 | APPR |
| [P120020](/device/P120020.md) | SUPERA PERIPHERAL STENT SYSTEM | Abbott Vascular (Idef Technologies Inc) | Mar 28, 2014 | APPR |
| [P110040](/device/P110040.md) | MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM | Medtronic Vascular | Sep 19, 2013 | APWD |
| [P120002](/device/P120002.md) | SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS | Cordis US Corporation | Nov 7, 2012 | APPR |
| [P110023](/device/P110023.md) | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) | Medtronic Vascular, Inc. | Mar 7, 2012 | APPR |
| [P070014S010](/device/P070014S010.md) | LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS | Bard Peripheral Vascular, Inc. | Dec 23, 2010 | APPR |
| [P070014](/device/P070014.md) | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | Bard Peripheral Vascular, Inc. | Feb 13, 2009 | APPR |
| [P040037S007](/device/P040037S007.md) | GORE VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Aug 14, 2008 | APPR |
| [P040037](/device/P040037.md) | VIABAHN ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | Jun 14, 2005 | APPR |
| [P000033](/device/P000033.md) | INTRA COIL SELF-EXPANDING PERIPHERAL STENT | Medtronic Vascular, Inc. | Apr 3, 2002 | APWD |

## Top Applicants

- W. L. Gore & Associates, Inc. — 4 clearances
- Bard Peripheral Vascular, Inc. — 3 clearances
- Medtronic Vascular, Inc. — 3 clearances
- Abbott Vascular (Idef Technologies Inc) — 1 clearance
- Biotronik AG — 1 clearance

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**Source:** [https://fda-staging.innolitics.com/productcode/NIP](https://fda-staging.innolitics.com/productcode/NIP)

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**Cite:** Innolitics at https://innolitics.com
