FDA Registration
Active
🇺🇸 United States
Spur Peripheral Retrievable Stent System
Reg #: 3008789872
·
FEI: 3008789872
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- REFLOW MEDICAL, INC
- Registration Number
- 3008789872
- FEI Number
- 3008789872
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 208 Avenida Fabricante, Suite 100
- City
- San Clemente
- State
- CA
- ZIP
- 92672
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN240048
Owner / Operator
- Firm Name
- Reflow Medical
- Operator Number
- 10034685
- Address
- 208 Avenida Fabricante, Suite 100
- City
- San Clemente
- State
- CA
- Postal Code
- 92672
- Country
- US
- Correspondent
- Angela Lamprey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Peripheral Temporary And Retrievable Stent System | SEU | Class 2 | Cardiovascular | No | 2025-06-03 |
Proprietary Names
Spur Peripheral Retrievable Stent System
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device