Product code NIM ยท Class 3
Stent, Carotid
0510(k)s in 12 months (0 all time)
7recalls in 12 months (25 all time)
0recalls that name a 510(k)
Top companies in NIM
| Company | 510(k)s | Recalls |
|---|---|---|
| INSPIREMD Inc | 0 | 6 |
| Abbott Vascular | 0 | 3 |
| Abbott Vascular-Cardiac Therapies dba Guidant Corporation | 0 | 3 |
| Boston Scientific Corporation | 0 | 3 |
| Cordis Corporation | 0 | 3 |
| Contego Medical LLC | 0 | 2 |
| Ev3, Inc. | 0 | 2 |
| Boston Scientific Cupertino, Corporation | 0 | 1 |
| Cardinal Health Inc. | 0 | 1 |
| Silk Road Medical Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | Contego Medical, Inc Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV- Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx40mm
Model/Catalog Number: CND1040 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 10mmx30mm
Model/Catalog Number: CND1030 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm
Model/Catalog Number: CND0940 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc CGuard Prime Carotid Stent System, 135cm, 9mx30mm
Model/Catalog Number: CND0930 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm
Model/Catalog Number: CND0840 Open, Classified |
NIM | None listed |
| Jun 5, 2026 | INSPIREMD Inc Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm
Model/Catalog Number: CND0830 Open, Classified |
NIM | None listed |
| Oct 10, 2025 | Contego Medical LLC Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0740-140-2, NG-NV-7-40, NG-0640-140-2, NG-NV-6-40 Open, Classified |
NIM | None listed |
| Aug 8, 2025 | Boston Scientific Corporation Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system.
Material numbers:
H7493915010240
CAROTID WALLSTENT MONORAIL 10.0-24;
H7493915010310
CAROT Open, Classified |
NIM | None listed |
| Feb 11, 2021 | Cordis Corporation PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920R Completed |
NIM | None listed |
| Jan 13, 2021 | Silk Road Medical Inc ENROUTE Transcarotid Stent System REF SR-XXYY-CS Terminated |
NIM | None listed |
| Nov 14, 2019 | Cardinal Health Inc. Cordis Precise Nitinol Stent System.
The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wir Open, Classified |
NIM | None listed |
| May 4, 2016 | Cordis Corporation Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Terminated |
NIM | None listed |
| May 4, 2016 | Cordis Corporation Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Terminated |
NIM | None listed |
| Dec 29, 2014 | Ev3, Inc. ev3, Protg Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require perc Terminated |
NIM | None listed |
| Dec 29, 2014 | Ev3, Inc. ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require pe Terminated |
NIM | None listed |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection Terminated |
NIM | None listed |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection sy Terminated |
NIM | None listed |
| Nov 10, 2010 | Abbott Vascular RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361
The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection sys Terminated |
NIM | None listed |
| Mar 16, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01)
The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter Terminated |
NIM | None listed |
| Mar 16, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01)
The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter o Terminated |
NIM | None listed |
| Jan 29, 2010 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851.
Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who re Terminated |
NIM | None listed |
| Sep 16, 2008 | Boston Scientific Cupertino, Corporation NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number 55-300, packaged in a PET tray manufactured by Boston Scientific Corp, Natick, MA. Terminated |
NIM | None listed |
| Aug 13, 2008 | Boston Scientific Corporation Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Numbe Terminated |
NIM | None listed |
| Aug 9, 2007 | Boston Scientific Corporation Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA Terminated |
NIM | None listed |
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