OAE · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
· Class 3
Overview
| Product Code | OAE |
|---|---|
| Device Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
For the treatment of atrial fibrillation.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220032 | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | Boston Scientific Corporation | Aug 8, 2023 | APPR |
| P220013 | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | ABBOTT MEDICAL | May 18, 2023 | APPR |
| P210027 | QDOT MICRO System | Biosense Webster, Inc. | Nov 23, 2022 | APPR |
| P200028 | DiamondTemp Ablation System | Medtronic, Inc. | Jan 28, 2021 | APPR |
| P150026 | HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM | Cardiofocus, Inc. | Apr 1, 2016 | APPR |
| P130026 | TACTICATH QUARTZ SET | St Jude Medical | Oct 24, 2014 | APPR |
| P100010 | 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
