NIQ · Coronary Drug-Eluting Stent
· Class 3
Overview
| Product Code | NIQ |
|---|---|
| Device Name | Coronary Drug-Eluting Stent |
| Device Class | Class 3 |
| Review Panel | |
| 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 | BioFreedom Drug Coated Coronary Stent System | Biosensors International USA, Inc. | Apr 14, 2022 | APWD |
| P210014 | 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 | ORSIRO Sirolimus Eluting Coronary Stent System | Biotronik AG | Feb 22, 2019 | APPR |
| P170008 | EluNIR Ridaforolimus Eluting Coronary Stent System | Medinol, Ltd. | Nov 28, 2017 | APPR |
| P160043 | RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM | Medtronic Vascular | Apr 28, 2017 | APPR |
| P150003 | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | Boston Scientific Corporation | Oct 2, 2015 | APPR |
| P110013 | RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM | Medtronic Vascular | Feb 17, 2012 | APPR |
| P110010 | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | Boston Scientific Corp | Nov 22, 2011 | APPR |
| P110019 | Xience Skypoint Everolimus Eluting Coronary Stent System | Abbott Vascular | Nov 1, 2011 | APPR |
| P100023 | ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) | Boston Scientific Corp | Apr 22, 2011 | APWD |
| P060008 | TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) | Boston Scientific Corp | Oct 10, 2008 | APWD |
| P070015 | XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS | Abbott Vascular, Inc. | Jul 2, 2008 | APWD |
| P060033 | ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM | Medtronic, Inc. | Feb 1, 2008 | APWD |
| P030025 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) | Boston Scientific Corp | Mar 4, 2004 | APWD |
| P020026 | 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
