Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1290](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1290) → DXX — System, Catheter Control, Steerable # DXX · System, Catheter Control, Steerable _Cardiovascular · 21 CFR 870.1290 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX ## Overview - **Product Code:** DXX - **Device Name:** System, Catheter Control, Steerable - **Regulation:** [21 CFR 870.1290](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1290) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 33) Showing 20 most recent of 33 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251792](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K251792.md) | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis, Inc. | Nov 6, 2025 | SESE | | [K243789](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K243789.md) | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | Sep 4, 2025 | SESE | | [K221464](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K221464.md) | CorPath GRX System | Corindus, Inc. | Jul 27, 2022 | SESE | | [K202275](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K202275.md) | CorPath GRX System | Corindus, Inc. | Dec 11, 2020 | SESE | | [K180517](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K180517.md) | CorPath GRX System | Corindus, Inc. | Mar 29, 2018 | SESE | | [K173806](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K173806.md) | CorPath GRX System | Corindus, Inc. | Mar 1, 2018 | SESE | | [K173288](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K173288.md) | CorPath GRX System | Corindus, Inc. | Feb 15, 2018 | SESE | | [K160121](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K160121.md) | CorPath GRX System | Corindus, Inc. | Oct 27, 2016 | SESE | | [K152999](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K152999.md) | CorPath 200 System | Corindus, Inc. | Mar 18, 2016 | SESE | | [K150892](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K150892.md) | CorPath 200 System | Corindus, Inc. | Oct 2, 2015 | SESE | | [K151730](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K151730.md) | Magellan Robotic System | Hansen Medical, Inc. | Jul 23, 2015 | SESE | | [K143227](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K143227.md) | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | Jul 1, 2015 | SESE | | [K150312](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K150312.md) | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | Jun 17, 2015 | SESE | | [K141530](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K141530.md) | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | Dec 18, 2014 | SESE | | [K140804](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K140804.md) | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | Sep 3, 2014 | SESE | | [K141614](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K141614.md) | MAGELLAN ROBOTIC SYSTEM | Hansen Medical | Aug 7, 2014 | SESE | | [K141822](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K141822.md) | SENSEI X ROBOTIC CATHETER SYSTEM | Hanson Medical, Inc. | Aug 5, 2014 | SESE | | [K132369](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K132369.md) | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | Sep 27, 2013 | SESE | | [K122488](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K122488.md) | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | Catheter Robotics, Inc. | Nov 20, 2012 | SESE | | [K120834](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX/K120834.md) | CORPATH 200 SYSTEM | Corindus, Inc. | Jul 19, 2012 | SESE | ## Top Applicants - Corindus, Inc. — 9 clearances - Hansen Medical, Inc. — 9 clearances - Stereotaxis, Inc. — 8 clearances - Catheter Research C/O Burditt, Bowles & Radzius — 2 clearances - Catheter Robotics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXX) **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