# OAE · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

_ ·  · Class 3_

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

## Overview

- **Product Code:** OAE
- **Device Name:** Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Life-sustaining:** yes

## Identification

For the treatment of atrial fibrillation.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220032](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P220032.md) | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | Boston Scientific Corporation | Aug 8, 2023 | APPR |
| [P220013](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P220013.md) | TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C | ABBOTT MEDICAL | May 18, 2023 | APPR |
| [P210027](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P210027.md) | QDOT MICRO™ System | Biosense Webster, Inc. | Nov 23, 2022 | APPR |
| [P200028](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P200028.md) | DiamondTemp Ablation System | Medtronic, Inc. | Jan 28, 2021 | APPR |
| [P150026](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P150026.md) | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM | Cardiofocus, Inc. | Apr 1, 2016 | APPR |
| [P130026](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P130026.md) | TACTICATH QUARTZ SET | St Jude Medical | Oct 24, 2014 | APPR |
| [P100010](https://fda.innolitics.com/submissions/CV/CV-misc/OAE/P100010.md) | ARCTIC FRONT CRYOCATHETER SYSTEM | Medtronic Cryocath, LP | Dec 17, 2010 | APPR |

## Top Applicants

- ABBOTT MEDICAL — 1 clearance
- Biosense Webster, Inc. — 1 clearance
- Boston Scientific Corporation — 1 clearance
- Cardiofocus, Inc. — 1 clearance
- Medtronic Cryocath, LP — 1 clearance

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

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