FDA Registration
Inactive
🇺🇸 United States
CGuard Prime Carotid Stent System
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INSPIREMD, INC.
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6303 Waterford District Dr Ste 215
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
Regulatory Submissions
- PMA Number
- P240029
Owner / Operator
- Firm Name
- InspireMD, Inc.
- Operator Number
- 10093692
- Address
- 6303 Waterford District Dr, Ste 215
- City
- Miami
- State
- FL
- Postal Code
- 33126
- Country
- US
- 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
Repack or Relabel Medical Device