Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I
FDA premarket approval P240009/S005 · decided 2025-09-19
Approval details
- PMA number
- P240009
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard I
- Generic name
- Stent, carotid
- Applicant
- Contego Medical, Inc.
- Date received
- 2025-08-21
- Decision date
- 2025-09-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- to a add new minimum sterilization load for the current chamber and add a new sterilization chamber at the contract sterilizer
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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 |