Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection
FDA premarket approval P240009/S007 · decided 2026-01-28
Approval details
- PMA number
- P240009
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection
- Generic name
- Stent, carotid
- Applicant
- Contego Medical, Inc.
- Date received
- 2025-12-18
- Decision date
- 2026-01-28
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- removal of destructive testing at product release, updated in-process monitoring, and the addition of a pneumatic hypotube crimper for wire attachment
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |