Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
FDA premarket approval P240009 · decided 2024-10-11
Approval details
- PMA number
- P240009
- Trade name
- Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
- Generic name
- Stent, carotid
- Applicant
- Contego Medical, Inc.
- Date received
- 2024-03-29
- Decision date
- 2024-10-11
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- This Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below: Patients with symptomatic stenosis of the common or internal carotid artery with >=50% as determined by angiography using NASCET methodology, or Patients with asymptomatic stenosis of the
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Excipio LV Prime Thrombectomy Device (K251485) | Contego Medical, Inc. | 2025-06-13 |
| Excipio SV Aspiration Catheter and Tubing (K230030) | Contego Medical, Inc. | 2023-05-30 |
| Excipio LV Thrombectomy Device (K223897) | Contego Medical, Inc. | 2023-02-17 |
| Excipio SV Thrombectomy Device (K221204) | Contego Medical, Inc. | 2022-06-23 |
| Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K221339) | Contego Medical, Inc. | 2022-06-09 |