Product code DRF
- Device name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1220
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990025S074 | NAVISTAR Electrophysiology Catheter | Biosense Webster, Inc. | 2025-02-25 |
| P990025S073 | NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol | Biosense Webster, Inc. | 2024-11-20 |
| P990025S072 | nMARQ Catheter Interference Cable | Biosense Webster, Inc. | 2024-11-15 |
| P990025S071 | NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables | Biosense Webster, Inc. | 2023-06-12 |
| P990025S070 | NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, | Biosense Webster, Inc. | 2022-09-30 |
| P990025S069 | NAVISTAR | Biosense Webster, Inc. | 2022-09-09 |
| P990025S067 | NAVISTAR | Biosense Webster, Inc. | 2022-03-08 |
| P990025S068 | Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter | Biosense Webster, Inc. | 2021-09-22 |
| P990025S065 | CELSIUS and EZ STEER | Biosense Webster, Inc. | 2021-09-22 |
| P990025S066 | Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar | Biosense Webster, Inc. | 2021-07-09 |
| P990025S063 | Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter | Biosense Webster, Inc. | 2021-04-28 |
| P990025S064 | NAVISTAR™RMT THERMOCOOL, NAVISTAR™DS, EZ STEER™NAV DS | Biosense Webster, Inc. | 2021-04-27 |
| P990025S062 | Navistar, Navistar RMT, EZ Steer Nav Bi-directional | Biosense Webster, Inc. | 2021-04-07 |
| P990025S061 | Navistar EP, EZ Steer Nav Bi-Directional | Biosense Webster, Inc. | 2021-02-02 |
| P990025S060 | EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter | Biosense Webster, Inc. | 2020-09-24 |
| P990025S059 | EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables | Biosense Webster, Inc. | 2020-04-16 |
| P990025S058 | Navistar Electrophysiology Catheter | Biosense Webster, Inc. | 2020-02-26 |
| P990025S057 | Navistar RMT Catheter | Biosense Webster, Inc. | 2019-03-08 |
| P990025S056 | Navistar RMT Electrophysiology Catheter | Biosense Webster, Inc. | 2018-07-30 |
| P990025S052 | Navi-Star Diagnostics/ Ablation Deflectable Tip Catheter | Biosense Webster, Inc. | 2017-10-24 |
| P990025S055 | Navi-Star Diagnostic/Ablation Deflectable Tip Catheter | Biosense Webster, Inc. | 2017-10-17 |
| P990025S054 | NaviStar Catheter | Biosense Webster, Inc. | 2017-10-10 |
| P990025S049 | NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER | Biosense Webster, Inc. | 2017-08-10 |
| P990025S053 | EZ Steer Navigational 4mm (TC) | Biosense Webster, Inc. | 2017-07-27 |
| P990025S051 | NAVISTAR RMT; NAVISTAR RMT DS CATHETER | Biosense Webster, Inc. | 2017-07-17 |
| P990025S050 | NAVISTAR ELECTROPHYSIOLOGY CATHETER | Biosense Webster, Inc. | 2016-09-21 |
| P990025S048 | NAVI-STAR and EZ Steer Nav Bi-Directional Catheter | Biosense Webster, Inc. | 2016-04-25 |
| P950005S018 | CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S | Biosense Webster, Inc. | 2005-12-16 |
| P990071S005 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | Biosense Webster, Inc. | 2005-06-06 |
| P990071S006 | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR | Biosense Webster, Inc. | 2005-03-21 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252794 | Vision-MR™ Diagnostic Catheter | Imricor Medical Systems, Inc. | 2026-01-08 |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | Stereotaxis, Inc. | 2025-07-23 |
| K250310 | VIKING™ Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | 2025-06-27 |
| K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2024-11-01 |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | 2024-09-06 |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023-12-02 |
| K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-10-27 |
| K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-09-29 |
| K230503 | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | Boston Scientific | 2023-04-25 |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2022-06-10 |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | 2022-02-14 |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | CathRx, Ltd. | 2022-02-10 |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | 2022-01-26 |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | 2021-10-15 |
| K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021-09-14 |
| K211375 | Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2021-09-10 |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | 2021-09-02 |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2021-03-05 |
| K193632 | LassoStar Circular Mapping Catheter | Biosense Webster, Inc. | 2020-06-30 |
| K191880 | Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-12-11 |
| K192360 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2019-10-25 |
| K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | ABBOTT MEDICAL | 2019-09-17 |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | 2019-07-30 |
| K190132 | Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter | Medtronic | 2019-07-30 |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC | 2019-07-01 |
| K183649 | Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | 2019-06-07 |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | Baylis Medical Company, Inc. | 2019-06-07 |
| K182386 | Reprocessed Supreme Diagnostic Electrophysiology Catheter | Innovative Health, LLC | 2019-04-23 |
| K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2017-10-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729879008 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879619 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879602 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879596 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879374 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879343 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879305 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879107 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879091 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879077 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879060 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879053 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879046 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879039 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729879015 | Viking™ Soft Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729082002 | SteeroCath-Dx™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729877998 | Cable, Orbiter™ PV | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729335023 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729335009 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729334996 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270256 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270249 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270188 | Polaris X™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270171 | Polaris X™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270164 | Polaris X™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270140 | Polaris X™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729270133 | Polaris X™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729269731 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729085249 | Electrophysiology Cable | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729082026 | SteeroCath-Dx™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |