Product code QRH
- Device name
- Catheter, Balloon, Urethral, Drug-Coated
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Dilate urethral strictures
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P210020S010 | Optilume Urethral Drug Coated Balloon Catheter | Urotronic, Inc. | 2025-06-23 |
| P210020S009 | Optilume Urethral Drug Coated Balloon catheter | Urotronic, Inc. | 2024-01-13 |
| P210020S008 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2023-04-25 |
| P210020S006 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-09-29 |
| P210020S005 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-06-10 |
| P210020S004 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-05-17 |
| P210020S003 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-02-03 |
| P210020S002 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-01-27 |
| P210020S001 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-01-19 |
| P210020 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2021-12-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00859937006209 | Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006315 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006308 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006292 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006285 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006278 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006261 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006254 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006247 | Optilume Urethral Drug Coated Balloon Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006216 | Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00859937006193 | Optilume Urethral Drug Coated Balloon Catheter & Basic Catheter Kit | Urotronic, Inc. | 2026-02-09 |
| 00853095008242 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008273 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008280 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008297 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008303 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008310 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008327 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |
| 00853095008334 | Optilume Urethral Drug Coated Balloon | Urotronic, Inc. | 2022-12-04 |