FDA Registration
Active
🇺🇸 United States
Expanse Medical Inc.
Reg #: 3017823876
·
FEI: 3017823876
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Expanse Medical Inc.
- Registration Number
- 3017823876
- FEI Number
- 3017823876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7060Koll Center Parkway, Suite 300
- City
- Pleasanton
- State
- CA
- ZIP
- 94566
- Country
- US
Regulatory Submissions
- 510(k) Number
- K234073
Owner / Operator
- Firm Name
- Expanse Medical Inc.
- Operator Number
- 10088957
- Address
- 7060 Koll Center Parkway Suite 300, |Pleasanton
- City
- CA
- State
- US
- Country
- 94566
- Correspondent
- Shiva Ardakani
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2024-12-09 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2024-12-09 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2026-05-27 |
Proprietary Names
FLOWRUNNER Aspiration System
FLOWRUNNER Aspiration System SP 7F
FLOWRUNNER Aspiration System 7F
Establishment Types
Manufacture Medical Device