Raleigh, NC, US · 5 510(k) clearances · 9 PMAs · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Class II | Cardiovascular | 4 | 2025-06-13 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Class II | Cardiovascular | 1 | 2022-06-09 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-29 | P240009-S012 | Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection | 30-Day Notice | NIM | — | — |
| 2026-05-27 | P240009-S011 | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | 30-Day Notice | NIM | — | — |
| 2026-05-08 | P240009-S008 | Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection | 30-Day Notice | NIM | — | — |
| 2026-01-28 | P240009-S007 | Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection | 135 Review Track For 30-Day Notice | NIM | — | — |
| 2025-09-19 | P240009-S005 | Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I | 30-Day Notice | NIM | — | — |
| 2025-08-22 | P240009-S004 | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | Special (Immediate Track) | NIM | — | — |
| 2024-11-15 | P240009-S002 | Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection | 30-Day Notice | NIM | — | — |
| 2024-11-15 | P240009-S001 | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection | 30-Day Notice | NIM | — | — |
| 2024-10-11 | P240009 | Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection | Original | NIM | — | — |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-06-29 | Class II | Ongoing | Z-2911-2026 | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP … | — | Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may … |
| 2025-09-04 | Class II | Ongoing | Z-0131-2026 | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP … | — | Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-06-13 | K251485 | Excipio LV Prime Thrombectomy Device | QEW | Class II | Cardiovascular |
| 2023-05-30 | K230030 | Excipio SV Aspiration Catheter and Tubing | QEW | Class II | Cardiovascular |
| 2023-02-17 | K223897 | Excipio LV Thrombectomy Device | QEW | Class II | Cardiovascular |
| 2022-06-23 | K221204 | Excipio SV Thrombectomy Device | QEW | Class II | Cardiovascular |
| 2022-06-09 | K221339 | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection | LIT | Class II | Cardiovascular |