Home › Device types › NIQ
Coronary Drug-Eluting Stent
FDA product code NIQ · Class 3 · Unknown
1,466
Registered devices
128,712
Adverse events
6
Recalls
0
510(k) clearances
Devices with this code
XIENCE Skypoint™ — ABBOTT VASCULAR INC.XIENCE ALPINE — ABBOTT VASCULAR INC.EluNIRTM Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.XIENCE XPEDITION — ABBOTT VASCULAR INC.XIENCE XPEDITION — ABBOTT VASCULAR INC.XIENCE ALPINE — ABBOTT VASCULAR INC.Endeavor® sprint — MEDTRONIC, INC.Promus ELITE™ — BOSTON SCIENTIFIC CORPORATIONPromus PREMIER™ — BOSTON SCIENTIFIC CORPORATIONEluNIR Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.SYNERGY™ — BOSTON SCIENTIFIC CORPORATIONXIENCE ALPINE — ABBOTT VASCULAR INC.PROMUS Element™ Plus — BOSTON SCIENTIFIC CORPORATIONXIENCE XPEDITION — ABBOTT VASCULAR INC.XIENCE ALPINE — ABBOTT VASCULAR INC.EluNIR Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.XIENCE XPEDITION — ABBOTT VASCULAR INC.EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.Orsiro Mission — Biotronik AGSYNERGY™ — BOSTON SCIENTIFIC CORPORATIONXIENCE V — ABBOTT VASCULAR INC.Resolute Onyx™ — MEDTRONIC, INC.SYNERGY™ XD — BOSTON SCIENTIFIC CORPORATIONResolute Onyx™ — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-25 | Abbott Vascular | Incorrect expiration date |
| 2013-10-07 | Medtronic Vascular, Inc. | A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly r |
| 2009-08-06 | Medtronic Vascular Galway Limited | The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and In |
| 2005-01-12 | Cordis Corporation | Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met. |
| 2004-11-18 | Cordis Corporation | Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004. |
| 2004-07-01 | Boston Scientific Scimed | On a few occasions the balloon has failed to deflate within one minute after deployment of the stent. |
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