FDA Registration
Active
🇺🇸 United States
Optilume® Urethral Drug Coated Balloon
Reg #: 3015228875
·
FEI: 3015228875
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- UROTRONIC INC
- Registration Number
- 3015228875
- FEI Number
- 3015228875
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2495 Xenium Lane North
- City
- Plymouth
- State
- MN
- ZIP
- 55441
- Country
- US
Regulatory Submissions
- PMA Number
- P210020
Owner / Operator
- Firm Name
- Urotronic Inc
- Operator Number
- 10063084
- Address
- 2495 Xenium Lane North
- City
- Plymouth
- State
- MN
- Postal Code
- 55441
- Country
- US
- Correspondent
- Alex Zuniga
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Balloon, Urethral, Drug-Coated | QRH | Class 3 | Unknown | No | 2021-12-06 |
Proprietary Names
Optilume® Urethral Drug Coated Balloon
Establishment Types
Manufacture Medical Device