QZI · Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
· Class 3
Overview
| Product Code | QZI |
|---|---|
| Device Name | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
| Device Class | Class 3 |
| Review Panel |
Identification
For the treatment of atrial fibrillation.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250022 | Volt PFA System | ABBOTT MEDICAL | Dec 19, 2025 | APPR |
| P240044 | Globe® Pulsed Field System | Kardium, Inc. | Aug 27, 2025 | APPR |
| P240006 | VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) | Biosense Webster, Inc. | Nov 6, 2024 | APPR |
| P240013 | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | Oct 24, 2024 | APPR |
| P230030 | FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, | Farapulse, Inc. | Jan 30, 2024 | APPR |
| P230017 | PulseSelect Pulsed Field Ablation (PFA) system | Medtronic, Inc. | Dec 13, 2023 | APPR |
Top Applicants
- Medtronic, Inc. — 2 clearances
- ABBOTT MEDICAL — 1 clearance
- Biosense Webster, Inc. — 1 clearance
- Farapulse, Inc. — 1 clearance
- Kardium, Inc. — 1 clearance
