# OAD · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

_ ·  · Class 3_

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

## Overview

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

## Identification

For the treatment of atrial flutter.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150005](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P150005.md) | BLAZER OPEN-IRRIGATED ABLATION CATHETER | Boston Scientific Corp | Feb 24, 2016 | APPR |
| [P110016](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P110016.md) | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | ABBOTT MEDICAL | Jan 25, 2012 | APPR |
| [P050024](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P050024.md) | CRYOCOR CRYOABLATION SYSTEM | Boston Scientific Corp | Aug 1, 2007 | APWD |
| [P060019](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P060019.md) | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | Irvine Biomedical, Inc. | Mar 16, 2007 | APPR |
| [P040042](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P040042.md) | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER | Irvine Biomedical,Inc.(Ibi) | Nov 18, 2005 | APPR |
| [P030031](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P030031.md) | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | Biosense Webster, Inc. | Nov 5, 2004 | APPR |
| [P020025](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P020025.md) | EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM | Boston Scientific | Aug 25, 2003 | APPR |
| [P010068](https://fda.innolitics.com/submissions/CV/CV-misc/OAD/P010068.md) | NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER | Biosense Webster, Inc. | Sep 27, 2002 | APPR |

## Top Applicants

- Biosense Webster, Inc. — 2 clearances
- Boston Scientific Corp — 2 clearances
- ABBOTT MEDICAL — 1 clearance
- Boston Scientific — 1 clearance
- Irvine Biomedical, Inc. — 1 clearance

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

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