OAD · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
· Class 3
Overview
| Product Code | OAD |
|---|---|
| Device Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device Class | Class 3 |
| Review Panel | |
| Life-Sustaining | Yes |
Identification
For the treatment of atrial flutter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P150005 | BLAZER OPEN-IRRIGATED ABLATION CATHETER | Boston Scientific Corp | Feb 24, 2016 | APPR |
| P110016 | 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 | CRYOCOR CRYOABLATION SYSTEM | Boston Scientific Corp | Aug 1, 2007 | APWD |
| P060019 | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF | Irvine Biomedical, Inc. | Mar 16, 2007 | APPR |
| P040042 | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER | Irvine Biomedical,Inc.(Ibi) | Nov 18, 2005 | APPR |
| P030031 | BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS | Biosense Webster, Inc. | Nov 5, 2004 | APPR |
| P020025 | EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM | Boston Scientific | Aug 25, 2003 | APPR |
| P010068 | 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
