DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording
Cardiovascular · 21 CFR 870.1220 · Class 2
Overview
| Product Code | DRF |
|---|---|
| Device Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 186)
Showing 20 most recent of 186 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252794 | Vision-MR Diagnostic Catheter | Imricor Medical Systems, Inc. | Jan 8, 2026 | SESE |
| K250590 | MAGiC Sweep EP Mapping Catheter | Stereotaxis, Inc. | Jul 23, 2025 | SESE |
| K250310 | VIKING Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | Jun 27, 2025 | SESE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Nov 1, 2024 | SESE |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | Sep 6, 2024 | SESE |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | Dec 2, 2023 | SESE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Oct 27, 2023 | SESE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 29, 2023 | SESE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | Boston Scientific | Apr 25, 2023 | SESE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | Dec 30, 2022 | SESE |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | Jun 10, 2022 | SESE |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | Feb 14, 2022 | SESE |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | CathRx, Ltd. | Feb 10, 2022 | SESE |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | Jan 26, 2022 | SESE |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | Oct 15, 2021 | SESE |
| K211494 | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 14, 2021 | SESE |
| K211375 | Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 10, 2021 | SESE |
| K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | Sep 2, 2021 | SESE |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | Mar 5, 2021 | SESE |
| K193632 | LassoStar Circular Mapping Catheter | Biosense Webster, Inc. | Jun 30, 2020 | SESE |
Top Applicants
- Biosense Webster, Inc. — 20 clearances
- St Jude Medical — 14 clearances
- Ep Technologies, Inc. — 12 clearances
- C.R. Bard, Inc. — 11 clearances
- Irvine Biomedical, Inc. — 11 clearances
