Product code OAD ยท Class 3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
0510(k)s in 12 months (0 all time)
1recalls in 12 months (22 all time)
0recalls that name a 510(k)
Top companies in OAD
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 0 | 15 |
| St Jude Medical Inc | 0 | 3 |
| Endologix Inc | 0 | 2 |
| Johnson & Johnson Surgical Vision, Inc. | 0 | 1 |
| Medtronic, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Medtronic, Inc. Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. Open, Classified |
OAD | None listed |
| Nov 2, 2022 | Johnson & Johnson Surgical Vision, Inc. THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF Open, Classified |
OAD | None listed |
| Nov 28, 2018 | Boston Scientific Corporation IntellaNav MiFi Open-Irrigated Ablation Catheter
Product Usage:
Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Open, Classified |
OAD | None listed |
| Nov 28, 2018 | Boston Scientific Corporation IntellaTip MiFi Open-Irrigated Ablation Catheter
Product Usage:
Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Open, Classified |
OAD | None listed |
| Nov 28, 2018 | Boston Scientific Corporation Blazer Open-Irrigated Ablation Batch Catheter
Product Usage:
Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: C Open, Classified |
OAD | None listed |
| Aug 28, 2018 | Boston Scientific Corporation Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0, Open, Classified |
OAD | None listed |
| Nov 20, 2015 | Boston Scientific Corp IntellaTip MiFi XP Asymmetric (N4) Curve
7/110/2.5/8-10 ;
Material Number: M004PM4790N40; Catalog number: PM4790N4;
Cardiac:
The IntellaTip MiFi XP Catheter is indicated for interruption of accesso Terminated |
OAD | None listed |
| Nov 20, 2015 | Boston Scientific Corp IntellaTip MiFi XP Asymmetric (N4) Curve
7/110/2.5/8-8
Material Number: M004PM4500N40; Catalog number: PM4500N4;
Cardiac:
The IntellaTip MiFi XP Catheter is indicated for interruption of accessory Terminated |
OAD | None listed |
| Nov 20, 2015 | Boston Scientific Corp IntellaTip MiFi XP Asymmetric (N4) Curve
7/110/2.5/8-10 OUS;
Material Number: M004EPM4790N40; Catalog number: EPM4790N4;
Cardiac:
The IntellaTip MiFi XP Catheter is indicated for interruption of ac Terminated |
OAD | None listed |
| Nov 20, 2015 | Boston Scientific Corp IntellaTip MiFi XP Asymmetric (N4) Curve,
7/110/2.5/8-8 OUS;
Material Number: M004EPM4500N40; Catalog number: EPM4500N4;
Cardiac:
The IntellaTip MiFi XP Catheter is indicated for interruption of ac Terminated |
OAD | None listed |
| Mar 2, 2015 | Boston Scientific Corp IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters:
Material number: M004EPM96200, Catalog Number: EPM9620:
Material number: M004EPM9620K20, Catalog Number: EPM9620K2;
Material number : Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters fo Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for car Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters f Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for ca Terminated |
OAD | None listed |
| Jun 16, 2014 | Boston Scientific Corporation IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve.
The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for Terminated |
OAD | None listed |
| Nov 8, 2013 | St. Jude Medical Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO.
Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ab Terminated |
OAD | None listed |
| Nov 6, 2013 | St. Jude Medical US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO.
The catheters are intended for use with a comp Terminated |
OAD | None listed |
| Feb 14, 2012 | St Jude Medical Inc The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Terminated |
OAD | None listed |
| Jan 11, 2010 | Endologix Inc Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000. Terminated |
OAD | None listed |
| Jan 11, 2010 | Endologix Inc Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998. Terminated |
OAD | None listed |
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