FDA Registration
Active
🇺🇸 United States
Spex Support Catheters
Reg #: 3027058844
·
FEI: 3027058844
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Reflow Medical
- Registration Number
- 3027058844
- FEI Number
- 3027058844
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20532 Crescent Bay Dr. Suite 100
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193012
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 |
|---|---|---|---|---|---|
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2020-04-01 |
Proprietary Names
Spex Support Catheters
Establishment Types
Manufacture Medical Device