Panels › Cardiovascular › Product code DRF · Class 2
Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation 870.1220
2510(k)s in 12 months (186 all time)
0recalls in 12 months (26 all time)
19recalls that name a 510(k)
Top companies in DRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biosense Webster, Inc. | 19 | 15 |
| Boston Scientific | 14 | 5 |
| St Jude Medical | 14 | 1 |
| Ep Technologies, Inc. | 12 | 0 |
| C.R. Bard, Inc. | 11 | 0 |
| Irvine Biomedical, Inc. | 11 | 0 |
| Cordis Webster, Inc. | 8 | 0 |
| Innovative Health, LLC | 6 | 0 |
| Medtronic | 5 | 1 |
| Cardima, Inc. | 5 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K262068 | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) CathRx, Ltd., AU | DRF |
| Jan 8, 2026 | K252794 | Vision-MR Diagnostic Catheter Imricor Medical Systems, Inc. | DRF |
| Jul 23, 2025 | K250590 | MAGiC Sweep EP Mapping Catheter Stereotaxis, Inc. | DRF |
| Jun 27, 2025 | K250310 | VIKING Fixed Curve Diagnostic Catheter Boston Scientific Corporation | DRF |
| Nov 1, 2024 | K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic Boston Scientific Corporation | DRF |
| Sep 6, 2024 | K233900 | Nordica PV Cryo Mapping Catheter Synaptic Medical Corporation | DRF |
| Dec 2, 2023 | K233397 | Cosine-10TM Diagnostic Catheter Medtronic, Inc. | DRF |
| Oct 27, 2023 | K233207 | Polaris X Unidirectional Steerable Diagnostic Catheter Boston Scientific Corporation | DRF |
| Sep 29, 2023 | K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter Boston Scientific Corporation | DRF |
| Apr 25, 2023 | K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable Boston Scientific | DRF |
| Dec 30, 2022 | K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter Shanghai Microport EP Medtech Co., Ltd., CN | DRF |
| Jun 10, 2022 | K220796 | IntellaMap Orion High Resolution Mapping Catheter Boston Scientific Corporation | DRF |
| Feb 14, 2022 | K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter Synaptic Medical Corporation | DRF |
| Feb 10, 2022 | K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable CathRx, Ltd., AU | DRF |
| Jan 26, 2022 | K211219 | LASSOSTAR NAV Circular Mapping Catheter Biosense Webster, Inc. | DRF |
| Oct 15, 2021 | K212593 | ViaCath, AcQRate Dx Steerable Catheter Biotronick, Inc. | DRF |
| Sep 14, 2021 | K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter Boston Scientific Corporation | DRF |
| Sep 10, 2021 | K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter Boston Scientific Corporation | DRF |
| Sep 2, 2021 | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter Biotronik, Inc. | DRF |
| Mar 5, 2021 | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Jun 30, 2020 | K193632 | LassoStar Circular Mapping Catheter Biosense Webster, Inc. | DRF |
| Dec 11, 2019 | K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter Innovative Health, LLC | DRF |
| Oct 25, 2019 | K192360 | IntellaMap Orion High Resolution Mapping Catheter Boston Scientific Corporation | DRF |
| Sep 17, 2019 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled ABBOTT MEDICAL | DRF |
| Jul 30, 2019 | K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter Medtronic | DRF |
| Jul 30, 2019 | K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardi Medtronic | DRF |
| Jul 1, 2019 | K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Jun 7, 2019 | K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable Baylis Medical Company, Inc., CA | DRF |
| Jun 7, 2019 | K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable Baylis Medical Company, Inc., CA | DRF |
| Apr 23, 2019 | K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter Innovative Health, LLC | DRF |
| Oct 23, 2017 | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC | DRF |
| Dec 13, 2016 | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm St Jude Medical | DRF |
| Dec 6, 2016 | K161769 | Reprocessed Supreme Diagnostic Electrophysiology Catheters Innovative Health, LLC | DRF |
| Nov 15, 2016 | K162892 | Achieve Advance Mapping Catheter Medtronic, Inc. | DRF |
| Oct 18, 2016 | K151139 | EasyMap MAP Catheter Medfact Engineering GmbH, DE | DRF |
| May 6, 2016 | K153139 | Achieve ST Mapping Catheter, Catheter Connecting Cable Medtronic, Inc. | DRF |
| Apr 11, 2016 | K160390 | Map-it Diagnostic Mapping Catheters Access Point Technologies Ep, Inc. | DRF |
| Jul 15, 2015 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Re St Jude Medical | DRF |
| Apr 1, 2015 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter St Jude Medical | DRF |
| Jan 8, 2015 | K143481 | IntellaMap Orion High Resolution Mapping Catheter Rhythmia Medical, Inc. | DRF |
| Mar 4, 2014 | K133028 | RITHM ID ELECTROPHYSIOLOGY CATHETER Synaptic Medical Limited, CN | DRF |
| Aug 14, 2013 | K130602 | LASSO NAV DUO LOOP CATHETER Biosense Webster, Inc. | DRF |
| Apr 18, 2013 | K122461 | RHYTHMIA MAPPING CATHETER Rhythmia Medical, Inc. | DRF |
| Mar 19, 2012 | K120544 | RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN St Jude Medical | DRF |
| Dec 5, 2011 | K113213 | LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 Biosense Webster, Inc. | DRF |
| May 2, 2011 | K101991 | WEBSTER DUO-DECAPOLAR CATHETER Biosense Webster, Inc. | DRF |
| Mar 18, 2011 | K102588 | ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE Medtronic Ablation Frontiers, LLC | DRF |
| Oct 18, 2010 | K102721 | LIVEWIRE ELECTOPHYSIOLOGY CATHETER St Jude Medical | DRF |
| Oct 15, 2010 | K101955 | ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 St Jude Medical | DRF |
| Aug 13, 2010 | K101623 | INQUIRY AFOCUSII DIAGNOSTIC CATHETER St Jude Medical | DRF |
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