Cardiovascular · 20 clearances · 11 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Boston Scientific Corporation | 8 | 0 | 2025-06-27 |
| Biosense Webster, Inc. | 2 | 0 | 2022-01-26 |
| Synaptic Medical Corporation | 2 | 0 | 2024-09-06 |
| Biotronick, Inc. | 1 | 0 | 2021-10-15 |
| Stereotaxis, Inc. | 1 | 0 | 2025-07-23 |
| Innovative Health, LLC | 1 | 0 | 2021-03-05 |
| Imricor Medical Systems, Inc. | 1 | 1 | 2026-01-08 |
| Biotronik, Inc. | 1 | 0 | 2021-09-02 |
| Medtronic, Inc. | 1 | 0 | 2023-12-02 |
| CathRx, Ltd. | 1 | 0 | 2022-02-10 |
| Shanghai Microport EP Medtech Co., Ltd. | 1 | 0 | 2022-12-30 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 93610 | CPT | — | Medium | CPT 93610 for intra-atrial recording probe with interpretation |
| 93620 | CPT | — | Medium | Alternative code for recording electrodes placed during cardiac procedure |
| Date | PMA # | Sponsor | Trade name | Type |
|---|---|---|---|---|
| 2025-02-25 | P990025-S074 | Biosense Webster, Inc. | NAVISTAR Electrophysiology Catheter | 30-Day Notice |
| 2024-11-20 | P990025-S073 | Biosense Webster, Inc. | NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol | 30-Day Notice |
| 2024-11-15 | P990025-S072 | Biosense Webster, Inc. | nMARQ Catheter Interference Cable | Normal 180 Day Track No User Fee |
| 2023-06-12 | P990025-S071 | Biosense Webster, Inc. | NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables | 30-Day Notice |
| 2022-09-30 | P990025-S070 | Biosense Webster, Inc. | NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, | 30-Day Notice |
| 2022-09-09 | P990025-S069 | Biosense Webster, Inc. | NAVISTAR | Normal 180 Day Track |
| 2022-03-08 | P990025-S067 | Biosense Webster, Inc. | NAVISTAR | Normal 180 Day Track |
| 2021-09-22 | P990025-S068 | Biosense Webster, Inc. | Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter | Normal 180 Day Track No User Fee |
| 2021-09-22 | P990025-S065 | Biosense Webster, Inc. | CELSIUS and EZ STEER | Real-Time Process |
| 2021-07-09 | P990025-S066 | Biosense Webster, Inc. | Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar | 30-Day Notice |
| 2021-04-28 | P990025-S063 | Biosense Webster, Inc. | Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter | 30-Day Notice |
| 2021-04-27 | P990025-S064 | Biosense Webster, Inc. | NAVISTARRMT THERMOCOOL, NAVISTARDS, EZ STEERNAV DS | 30-Day Notice |
| 2021-04-07 | P990025-S062 | Biosense Webster, Inc. | Navistar, Navistar RMT, EZ Steer Nav Bi-directional | Special (Immediate Track) |
| 2021-02-02 | P990025-S061 | Biosense Webster, Inc. | Navistar EP, EZ Steer Nav Bi-Directional | 30-Day Notice |
| 2020-09-24 | P990025-S060 | Biosense Webster, Inc. | EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter | 30-Day Notice |
| 2020-04-16 | P990025-S059 | Biosense Webster, Inc. | EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables | 30-Day Notice |
| 2020-02-26 | P990025-S058 | Biosense Webster, Inc. | Navistar Electrophysiology Catheter | 30-Day Notice |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-01-08 | K252794 | Imricor Medical Systems, Inc. | Vision-MR Diagnostic Catheter |
| 2025-07-23 | K250590 | Stereotaxis, Inc. | MAGiC Sweep EP Mapping Catheter |
| 2025-06-27 | K250310 | Boston Scientific Corporation | VIKING Fixed Curve Diagnostic Catheter |
| 2024-11-01 | K240366 | Boston Scientific Corporation | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter |
| 2024-09-06 | K233900 | Synaptic Medical Corporation | Nordica PV Cryo Mapping Catheter |
| 2023-12-02 | K233397 | Medtronic, Inc. | Cosine-10TM Diagnostic Catheter |
| 2023-10-27 | K233207 | Boston Scientific Corporation | Polaris X Unidirectional Steerable Diagnostic Catheter |
| 2023-09-29 | K232651 | Boston Scientific Corporation | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter |
| 2023-04-25 | K230503 | Boston Scientific | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable |
| 2022-12-30 | K210313 | Shanghai Microport EP Medtech Co., Ltd. | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter |
| 2022-06-10 | K220796 | Boston Scientific Corporation | IntellaMap Orion High Resolution Mapping Catheter |
| 2022-02-14 | K203793 | Synaptic Medical Corporation | RithmID-SD Steerable Diagnostic Electrophysiology Catheter |
| 2022-02-10 | K211327 | CathRx, Ltd. | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters |
| 2022-01-26 | K211219 | Biosense Webster, Inc. | LASSOSTAR NAV Circular Mapping Catheter |
| 2021-10-15 | K212593 | Biotronick, Inc. | ViaCath, AcQRate Dx Steerable Catheter |
| 2021-09-14 | K211494 | Boston Scientific Corporation | Polaris X Unidirectional Steerable Diagnostic Catheter |
| 2021-09-10 | K211375 | Boston Scientific Corporation | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter |
| 2021-09-02 | K201445 | Biotronik, Inc. | MultiCath, AcQRate Dx Fixed Curve Catheter |
| 2021-03-05 | K203261 | Innovative Health, LLC | Reprocessed Inquiry Steerable Diagnostic EP Catheter |
| 2020-06-30 | K193632 | Biosense Webster, Inc. | LassoStar Circular Mapping Catheter |