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) → MTD — Catheter, Intracardiac Mapping, High-Density Array # MTD · Catheter, Intracardiac Mapping, High-Density Array _Cardiovascular · 21 CFR 870.1220 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD ## Overview - **Product Code:** MTD - **Device Name:** Catheter, Intracardiac Mapping, High-Density Array - **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 34) Showing 20 most recent of 34 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K261012](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K261012.md) | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | Apr 23, 2026 | SESE | | [K253205](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K253205.md) | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | Mar 13, 2026 | SESE | | [K233433](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K233433.md) | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | Aug 7, 2024 | SESE | | [K241372](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K241372.md) | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | ABBOTT MEDICAL | Jul 9, 2024 | SESE | | [K231312](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K231312.md) | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster, Inc. | Jul 10, 2023 | SESE | | [K223666](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K223666.md) | Ablacath™ Mapping Catheter | Ablacon, Inc. | Mar 17, 2023 | SESE | | [K230253](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K230253.md) | OPTRELL™ Mapping Catheter with TRUEref™ Technology | Biosense Webster, Inc. | Mar 2, 2023 | SESE | | [K210766](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K210766.md) | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | Jun 21, 2022 | SESE | | [K211438](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K211438.md) | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | Mar 18, 2022 | SESE | | [K201806](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K201806.md) | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | Jun 23, 2021 | SESE | | [K201341](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K201341.md) | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | Sep 15, 2020 | SESE | | [K200212](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K200212.md) | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | Sep 3, 2020 | SESE | | [K201750](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K201750.md) | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | Aug 6, 2020 | SESE | | [K193237](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K193237.md) | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | Jul 31, 2020 | SESE | | [K172393](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K172393.md) | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | Apr 23, 2018 | SESE | | [K170819](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K170819.md) | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | Oct 16, 2017 | SESE | | [K163709](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K163709.md) | FIRMap Catheter | Abbott Electrophysiology | Feb 28, 2017 | SESE | | [K153093](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K153093.md) | FIRMap Catheter | Abbott Electrophysiology | Apr 7, 2016 | SESE | | [K142182](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K142182.md) | FRIMAP ADAPTER CONNECTOR (MAC) | Topera, Inc. | Sep 9, 2014 | SESE | | [K140733](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD/K140733.md) | CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER | Boston Scientific Corporation | Apr 28, 2014 | SESE | ## Top Applicants - Biosense Webster, Inc. — 8 clearances - Boston Scientific Corp — 5 clearances - Acutus Medical, Inc. — 3 clearances - Abbott Electrophysiology — 2 clearances - Cardiac Pathways Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MTD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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