Product code QZI
- Device name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- 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 the treatment of atrial fibrillation.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P240013S022 | Affera Ablation System | Medtronic, Inc. | 2026-05-28 |
| P240013S025 | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | 2026-05-15 |
| P240013S027 | Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension Cable | Medtronic, Inc. | 2026-05-13 |
| P230030S019 | FARAPULSE™ Pulsed Field Ablation System | Farapulse, Inc. | 2026-05-06 |
| P240013S024 | Sphere-9 Catheter | Medtronic, Inc. | 2026-04-21 |
| P250022S003 | Volt™ PFA System | ABBOTT MEDICAL | 2026-04-16 |
| P250022S004 | Volt™ PFA Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2026-04-13 |
| P230017S010 | PulseSelect Pulse Field Ablation (PFA) Catheter | Medtronic, Inc. | 2026-04-13 |
| P240013S023 | Sphere-9 Catheter; Tubing Set; Extension Cable | Medtronic, Inc. | 2026-04-02 |
| P250022S001 | Volt PFA Catheter Sensor Enabled™ | ABBOTT MEDICAL | 2026-03-23 |
| P240013S021 | Sphere-9 Catheter (AFR-00001) | Medtronic, Inc. | 2026-03-20 |
| P240013S020 | Sphere-9 Catheter (AFR-00001) | Medtronic, Inc. | 2026-03-06 |
| P240013S019 | HexaGen™ RF Generator | Medtronic, Inc. | 2026-03-03 |
| P240044S002 | Globe Catheter (601-01000) | Kardium, Inc. | 2026-02-18 |
| P230017S009 | PulseSelect™ Pulsed Field Ablation (PFA) system | Medtronic, Inc. | 2026-02-17 |
| P240006S014 | VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) | Biosense Webster, Inc. | 2026-02-12 |
| P230030S017 | FARAPULSE™ Pulsed Field Ablation System (FARAPULSE) | Farapulse, Inc. | 2026-01-13 |
| P230030S012 | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C | Farapulse, Inc. | 2026-01-12 |
| P240044S004 | Globe® Catheter; Globe® Pulsed Field System | Kardium, Inc. | 2026-01-09 |
| P240044S003 | Globe® Pulsed Field System | Kardium, Inc. | 2026-01-06 |
| P240006S013 | VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump | Biosense Webster, Inc. | 2026-01-02 |
| P240006S012 | TRUPULSE™ Generator | Biosense Webster, Inc. | 2025-12-23 |
| P250022 | Volt™ PFA System | ABBOTT MEDICAL | 2025-12-19 |
| P240013S018 | Sphere-9 TM Mapping and Ablation Catheter | Medtronic, Inc. | 2025-11-20 |
| P230017S008 | PulseSelect™ Pulsed Field Ablation (PFA) system | Medtronic, Inc. | 2025-10-08 |
| P240013S017 | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | 2025-10-07 |
| P230030S013 | FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul | Farapulse, Inc. | 2025-09-24 |
| P240013S016 | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | 2025-09-19 |
| P240006S011 | VARIPULSE™ Catheter | Biosense Webster, Inc. | 2025-09-10 |
| P240013S010 | Sphere-9™ Mapping and Ablation Catheter | Medtronic, Inc. | 2025-09-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000954321 | NA | MEDTRONIC, INC. | 2026-04-30 |
| 05415067053893 | Current™ | ST. JUDE MEDICAL, INC. | 2026-04-20 |
| 05415067052933 | Current™ | ST. JUDE MEDICAL, INC. | 2026-04-20 |
| 05415067056030 | Volt™ | ST. JUDE MEDICAL, INC. | 2026-02-25 |
| 05415067056023 | Volt™ | ST. JUDE MEDICAL, INC. | 2026-02-25 |
| 05415067056016 | Volt™ | ST. JUDE MEDICAL, INC. | 2026-02-25 |
| 05415067056009 | Volt™ | ST. JUDE MEDICAL, INC. | 2026-02-25 |
| 00199150003709 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2026-02-20 |
| 00763000993269 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2026-02-08 |
| 00191506057688 | FARASTAR™ | BOSTON SCIENTIFIC CORPORATION | 2026-01-20 |
| 00191506055073 | FARASTAR™ | BOSTON SCIENTIFIC CORPORATION | 2026-01-20 |
| 00191506047221 | FARAPOINT™ | BOSTON SCIENTIFIC CORPORATION | 2026-01-20 |
| 00191506047207 | FARAPOINT™ | BOSTON SCIENTIFIC CORPORATION | 2026-01-20 |
| 00191506043964 | FARASTAR™ | BOSTON SCIENTIFIC CORPORATION | 2026-01-20 |
| 05415067051417 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 05415067051516 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 05415067051554 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 05415067051615 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 05415067051721 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 05415067051752 | Current™ | ST. JUDE MEDICAL, INC. | 2026-01-06 |
| 07540162100321 | Globe® PF Generator | Kardium Inc | 2025-09-15 |
| 07540162100277 | Globe® Catheter Cable | Kardium Inc | 2025-09-15 |
| 00763000998332 | HexaFlow™ Irrigation Pump | MEDTRONIC, INC. | 2025-08-30 |
| 00763000995003 | N/A | MEDTRONIC, INC. | 2025-04-12 |
| 00763000973506 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2025-01-13 |
| 00763000973391 | Sphere-9™ Catheter | MEDTRONIC, INC. | 2024-12-06 |
| 00763000871925 | HexaPulse™ PF Generator | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871895 | HexaFlow™ Irrigation Pump | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871772 | NA | MEDTRONIC, INC. | 2024-11-04 |
| 00763000871741 | Sphere-9™ | MEDTRONIC, INC. | 2024-11-04 |