Product code QYI
- Device name
- Ablation Catheter, Renal Denervation
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- For denervating the renal nerves to lower blood pressure
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P220026S016 | Symplicity Spyral™ Renal Denervation Catheter | Medtronic, Inc. | 2026-03-25 |
| P220026S015 | Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter | Medtronic, Inc. | 2026-02-27 |
| P220023S009 | ReCor Paradise™ Catheter | Recor Medical, Inc. | 2025-09-11 |
| P220026S012 | Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter | Medtronic, Inc. | 2025-04-10 |
| P220026S011 | Symplicity Spyral Renal Denervation Catheter | Medtronic, Inc. | 2025-04-07 |
| P220023S008 | Paradise Ultrasound Renal Denervation System; Paradise Catheter | Recor Medical, Inc. | 2025-03-25 |
| P220026S013 | Symplicity Spyral Multi-Electrode Renal Denervation Catheter | Medtronic, Inc. | 2025-03-21 |
| P220023S007 | Paradise Ultrasound Renal Denervation System; Paradise™ Catheter | Recor Medical, Inc. | 2025-03-06 |
| P220023S006 | Paradise™ Ultrasound Renal Denervation System (Paradise System), Paradise™ Catheter | Recor Medical, Inc. | 2025-01-24 |
| P220023S004 | Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator | Recor Medical, Inc. | 2024-12-20 |
| P220023S005 | Paradise Ultrasound Renal Denervation System, Paradise Generator | Recor Medical, Inc. | 2024-12-19 |
| P220026S010 | Symplicity Spyral™ Renal Denervation System | Medtronic, Inc. | 2024-12-11 |
| P220023S003 | Paradise® Ultrasound Renal Denervation System | Recor Medical, Inc. | 2024-10-25 |
| P220026S009 | Symplicity G3 Renal Denervation RF Generator | Medtronic, Inc. | 2024-08-21 |
| P220026S005 | Symplicity G3™ Renal RF Generator | Medtronic, Inc. | 2024-07-16 |
| P220026S007 | Symplicity Spyral' Multi-Electrode Renal Denervation Catheter | Medtronic, Inc. | 2024-05-08 |
| P220026S006 | Symplicity Spyral™ Renal Denervation System | Medtronic, Inc. | 2024-04-10 |
| P220026S004 | Symplicity Spyral Multi-Electrode Renal Denervation Catheter | Medtronic, Inc. | 2024-02-29 |
| P220026S003 | Symplicity Spyral Multi Electrode Renal Denervation Catheter | Medtronic, Inc. | 2024-02-28 |
| P220026S001 | Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator | Medtronic, Inc. | 2024-02-15 |
| P220026S002 | Symplicity Spyral™ Renal Denervation System | Medtronic, Inc. | 2024-02-06 |
| P220023S002 | ReCor Paradise® Ultrasound Renal Denervation System | Recor Medical, Inc. | 2024-02-05 |
| P220023S001 | Paradise™ Ultrasound Renal Denervation System (Paradise System), Paradise™ Cartridge | Recor Medical, Inc. | 2023-12-06 |
| P220026 | Symplicity Spyral™ Renal Denervation System | Medtronic, Inc. | 2023-11-17 |
| P220023 | Paradise® Ultrasound Renal Denervation System | Recor Medical, Inc. | 2023-11-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810008950005 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950012 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950029 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950036 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950043 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950050 | Paradise® Connection Cable | Recor Medical, Inc. | 2023-12-11 |
| 00810008950067 | Paradise® Catheter | Recor Medical, Inc. | 2023-12-11 |
| 00810008950074 | Paradise® Cartridge | Recor Medical, Inc. | 2023-12-11 |
| 00810008950098 | Paradise® Remote | Recor Medical, Inc. | 2023-12-11 |
| 00810008950111 | Paradise® Generator | Recor Medical, Inc. | 2023-12-11 |
| 00810008950128 | Paradise® Generator | Recor Medical, Inc. | 2023-12-11 |
| 00763000354466 | Symplicity Spyral™ | MEDTRONIC, INC. | 2023-11-30 |
| 00763000387020 | Symplicity G3™ | MEDTRONIC, INC. | 2023-11-30 |