Product code OAE ยท Class 3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
0510(k)s in 12 months (0 all time)
0recalls in 12 months (34 all time)
0recalls that name a 510(k)
Top companies in OAE
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott | 0 | 9 |
| Boston Scientific Corporation | 0 | 7 |
| Biosense Webster, Inc. | 0 | 6 |
| EPIX THERAPEUTICS, INC | 0 | 6 |
| Abbott Laboratories Inc. (St Jude Medical) | 0 | 1 |
| CardioFocus, Inc. | 0 | 1 |
| Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | 0 | 1 |
| Medtronic Inc. Cardiac Rhythm Disease Management | 0 | 1 |
| St Jude Medical | 0 | 1 |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter Open, Classified |
OAE | None listed |
| Oct 10, 2025 | Abbott TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter Open, Classified |
OAE | None listed |
| Mar 10, 2025 | CardioFocus, Inc. CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is
introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory
Model: 18-5000 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific SMARTFREEZE CRYO CONSOLE:
Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Mat Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 Open, Classified |
OAE | None listed |
| Nov 12, 2024 | Boston Scientific Corporation Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000. Open, Classified |
OAE | None listed |
| Jan 25, 2024 | St. Jude Medical, Atrial Fibrillation Division, Inc. TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile. Open, Classified |
OAE | None listed |
| Jul 7, 2022 | Abbott Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation. Terminated |
OAE | None listed |
| Mar 24, 2022 | Abbott Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile. Terminated |
OAE | None listed |
| Mar 24, 2022 | Abbott Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile. Terminated |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259 Open, Classified |
OAE | None listed |
| Feb 22, 2021 | EPIX THERAPEUTICS, INC EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198 Open, Classified |
OAE | None listed |
| May 22, 2020 | Abbott TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a Terminated |
OAE | None listed |
| Apr 5, 2019 | Abbott Laboratories Inc. (St Jude Medical) TactiSys Quartz Equipment (with software version 1.7)
Model: PN-004 400
Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Terminated |
OAE | None listed |
| Mar 4, 2019 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal a Open, Classified |
OAE | None listed |
| May 28, 2015 | Biosense Webster, Inc. SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107.
Product Usage:
The use of the SMART ABLATE Generator and all accessories is indicated in combination with compat Terminated |
OAE | None listed |
| Mar 17, 2015 | St Jude Medical TactiSys Quartz Pack, PN-004 400.
For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz cathet Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Feb 7, 2012 | Biosense Webster, Inc. EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use.
The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-ele Terminated |
OAE | None listed |
| Nov 2, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US)
Product Usage: The Medtronic CryoCath System Terminated |
OAE | None listed |
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