QRH · Catheter, Balloon, Urethral, Drug-Coated
· Class 3
Overview
| Product Code | QRH |
|---|---|
| Device Name | Catheter, Balloon, Urethral, Drug-Coated |
| Device Class | Class 3 |
| Review Panel |
Identification
Dilate urethral strictures
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210020 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | Dec 3, 2021 | APPR |
Top Applicants
- Urotronic, Inc. — 1 clearance
