Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1220](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1220) → DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording # DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording _Cardiovascular · 21 CFR 870.1220 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF ## Overview - **Product Code:** DRF - **Device Name:** Catheter, Electrode Recording, Or Probe, Electrode Recording - **Regulation:** [21 CFR 870.1220](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1220) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K252794.md) | Vision-MR™ Diagnostic Catheter | Imricor Medical Systems, Inc. | Jan 8, 2026 | SESE | | [K250590](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K250590.md) | MAGiC Sweep™ EP Mapping Catheter | Stereotaxis, Inc. | Jul 23, 2025 | SESE | | [K250310](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K250310.md) | VIKING™ Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | Jun 27, 2025 | SESE | | [K240366](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K240366.md) | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Nov 1, 2024 | SESE | | [K233900](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K233900.md) | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | Sep 6, 2024 | SESE | | [K233397](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K233397.md) | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | Dec 2, 2023 | SESE | | [K233207](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K233207.md) | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Oct 27, 2023 | SESE | | [K232651](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K232651.md) | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 29, 2023 | SESE | | [K230503](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K230503.md) | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | Boston Scientific | Apr 25, 2023 | SESE | | [K210313](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K210313.md) | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | Dec 30, 2022 | SESE | | [K220796](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K220796.md) | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | Jun 10, 2022 | SESE | | [K203793](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K203793.md) | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | Feb 14, 2022 | SESE | | [K211327](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K211327.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K211219.md) | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | Jan 26, 2022 | SESE | | [K212593](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K212593.md) | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | Oct 15, 2021 | SESE | | [K211494](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K211494.md) | Polaris X Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 14, 2021 | SESE | | [K211375](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K211375.md) | Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | Sep 10, 2021 | SESE | | [K201445](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K201445.md) | MultiCath, AcQRate Dx Fixed Curve Catheter | Biotronik, Inc. | Sep 2, 2021 | SESE | | [K203261](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K203261.md) | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | Mar 5, 2021 | SESE | | [K193632](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF/K193632.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DRF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com