# QZI · Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/QZI

## Overview

- **Product Code:** QZI
- **Device Name:** Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

For the treatment of atrial fibrillation.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250022](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P250022.md) | Volt™ PFA System | ABBOTT MEDICAL | Dec 19, 2025 | APPR |
| [P240044](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P240044.md) | Globe® Pulsed Field System | Kardium, Inc. | Aug 27, 2025 | APPR |
| [P240006](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P240006.md) | VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) | Biosense Webster, Inc. | Nov 6, 2024 | APPR |
| [P240013](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P240013.md) | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | Oct 24, 2024 | APPR |
| [P230030](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P230030.md) | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, | Farapulse, Inc. | Jan 30, 2024 | APPR |
| [P230017](https://fda.innolitics.com/submissions/CV/CV-misc/QZI/P230017.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/QZI](https://fda.innolitics.com/submissions/CV/CV-misc/QZI)

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