Product code NIQ ยท Class 3
Coronary Drug-Eluting Stent
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NIQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis Corporation | 0 | 2 |
| Abbott Vascular | 0 | 1 |
| Boston Scientific Scimed | 0 | 1 |
| Medtronic Vascular, Inc. | 0 | 1 |
| Medtronic Vascular Galway Limited | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2020 | Abbott Vascular Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, Terminated |
NIQ | None listed |
| Nov 5, 2013 | Medtronic Vascular, Inc. Resolute Integrity Zotarolimus-eluting Coronary Stent:
Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile.
Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc.
Minneapolis, MN.
In Terminated |
NIQ | None listed |
| Aug 21, 2009 | Medtronic Vascular Galway Limited Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured Terminated |
NIQ | None listed |
| Feb 18, 2005 | Cordis Corporation Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx Terminated |
NIQ | None listed |
| Jan 26, 2005 | Cordis Corporation Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. Terminated |
NIQ | None listed |
| Jul 20, 2004 | Boston Scientific Scimed TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm).
On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Corona Terminated |
NIQ | None listed |
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