# NIQ · Coronary Drug-Eluting Stent

_ ·  · Class 3_

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

## Overview

- **Product Code:** NIQ
- **Device Name:** Coronary Drug-Eluting Stent
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.  The drug coating is intended to inhibit restenosis.

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P190020](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P190020.md) | BioFreedom Drug Coated Coronary Stent System | Biosensors International USA, Inc. | Apr 14, 2022 | APWD |
| [P210014](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P210014.md) | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex | Advanced Bifurcation Systems, Inc. | Dec 13, 2021 | APWD |
| [P170030](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P170030.md) | ORSIRO Sirolimus Eluting Coronary Stent System | Biotronik AG | Feb 22, 2019 | APPR |
| [P170008](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P170008.md) | EluNIR™ Ridaforolimus Eluting Coronary Stent System | Medinol, Ltd. | Nov 28, 2017 | APPR |
| [P160043](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P160043.md) | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM | Medtronic Vascular | Apr 28, 2017 | APPR |
| [P150003](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P150003.md) | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | Boston Scientific Corporation | Oct 2, 2015 | APPR |
| [P110013](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P110013.md) | RESOLUTE MICROTRAC/RESOLUTE INTEGRITY  ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM | Medtronic Vascular | Feb 17, 2012 | APPR |
| [P110010](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P110010.md) | PROMUS ELEMENT PLUS  EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | Boston Scientific Corp | Nov 22, 2011 | APPR |
| [P110019](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P110019.md) | Xience Skypoint Everolimus Eluting Coronary Stent System | Abbott Vascular | Nov 1, 2011 | APPR |
| [P100023](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P100023.md) | ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) | Boston Scientific Corp | Apr 22, 2011 | APWD |
| [P060008](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P060008.md) | TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) | Boston Scientific Corp | Oct 10, 2008 | APWD |
| [P070015](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P070015.md) | XIENCE AND PROMUS EVEROLIMUS ELUTING  CORONARY STENT SYSTEMS | Abbott Vascular, Inc. | Jul 2, 2008 | APWD |
| [P060033](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P060033.md) | ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM | Medtronic, Inc. | Feb 1, 2008 | APWD |
| [P030025](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P030025.md) | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) | Boston Scientific Corp | Mar 4, 2004 | APWD |
| [P020026](https://fda.innolitics.com/submissions/CV/CV-misc/NIQ/P020026.md) | CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER | Cordis Corp. | Apr 24, 2003 | APWD |

## Top Applicants

- Boston Scientific Corp — 4 clearances
- Medtronic Vascular — 2 clearances
- Abbott Vascular — 1 clearance
- Abbott Vascular, Inc. — 1 clearance
- Advanced Bifurcation Systems, Inc. — 1 clearance

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

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