FDA Registration
Inactive
🇮🇱 Israel
CGuard Prime Carotid Stent System
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INSPIREMD, LTD.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4 Menorat HaMaor Street
- City
- Tel Aviv
- Country
- IL
Regulatory Submissions
- PMA Number
- P240029
Owner / Operator
- Firm Name
- InspireMD, Ltd.
- Operator Number
- 10093698
- Address
- 4 Menorat HaMaor Street
- City
- Tel Aviv
- State
- IL-NOTA
- Postal Code
- 6744832
- Country
- IL
- Correspondent
- Sonali Dewan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2025-06-25 |
Proprietary Names
CGuard Prime Carotid Stent System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device