Product code QZI ยท Class 3
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
0510(k)s in 12 months (0 all time)
4recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in QZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 5 |
| Biosense Webster, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Aug 8, 2025 | Boston Scientific Corporation FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 Open, Classified |
QZI | None listed |
| Feb 28, 2025 | Biosense Webster, Inc. VARIPULSE Bi-Directional Ablation Catheter REF D141201.
The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used fo Completed |
QZI | None listed |
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