# NIM · Stent, Carotid

_ ·  · Class 3_

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

## Overview

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

## Identification

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

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P240029](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P240029.md) | CGuard Prime Carotid Stent System | InspireMD, Ltd. | Jun 23, 2025 | APPR |
| [P210030](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P210030.md) | Roadsaver/CASPER Carotid Stent Device | MicroVention, Inc. | Nov 20, 2024 | APPR |
| [P240009](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P240009.md) | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | Oct 11, 2024 | APPR |
| [P180010](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P180010.md) | Gore Carotid Stent | W. L. Gore & Associates, Inc. | Nov 1, 2018 | APWD |
| [P140026](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P140026.md) | ENROUTE TRANSCAROTID STENT SYSTEM | Boston Scientific Corporation | May 18, 2015 | APPR |
| [P050019](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P050019.md) | CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS | Boston Scientific Corp | Oct 23, 2008 | APPR |
| [P070012](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P070012.md) | EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM | Medtronic Vascular | Oct 23, 2007 | APWD |
| [P060001](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P060001.md) | PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS | Medtronic Vascular, Inc. | Jan 24, 2007 | APPR |
| [P050025](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P050025.md) | ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM | Boston Scientific | Oct 27, 2006 | APPR |
| [P030047](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P030047.md) | CORDIS PRECISE NITINOL STENT SYSTEM | Cordis US Corporation | Sep 22, 2006 | APPR |
| [P040038](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P040038.md) | XACT CAROTID STENT SYSTEM | Abbott Vascular, Inc. | Sep 6, 2005 | APPR |
| [P040012](https://fda.innolitics.com/submissions/CV/CV-misc/NIM/P040012.md) | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM | Abbott Vascular | Aug 30, 2004 | APPR |

## Top Applicants

- Abbott Vascular — 1 clearance
- Abbott Vascular, Inc. — 1 clearance
- Boston Scientific — 1 clearance
- Boston Scientific Corp — 1 clearance
- Boston Scientific Corporation — 1 clearance

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

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