DXX · System, Catheter Control, Steerable
Cardiovascular · 21 CFR 870.1290 · Class 2
Overview
| Product Code | DXX |
|---|---|
| Device Name | System, Catheter Control, Steerable |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. | Nov 6, 2025 | SESE |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | Sep 4, 2025 | SESE |
| K221464 | CorPath GRX System | Corindus, Inc. | Jul 27, 2022 | SESE |
| K202275 | CorPath GRX System | Corindus, Inc. | Dec 11, 2020 | SESE |
| K180517 | CorPath GRX System | Corindus, Inc. | Mar 29, 2018 | SESE |
| K173806 | CorPath GRX System | Corindus, Inc. | Mar 1, 2018 | SESE |
| K173288 | CorPath GRX System | Corindus, Inc. | Feb 15, 2018 | SESE |
| K160121 | CorPath GRX System | Corindus, Inc. | Oct 27, 2016 | SESE |
| K152999 | CorPath 200 System | Corindus, Inc. | Mar 18, 2016 | SESE |
| K150892 | CorPath 200 System | Corindus, Inc. | Oct 2, 2015 | SESE |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | Jul 23, 2015 | SESE |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | Jul 1, 2015 | SESE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | Jun 17, 2015 | SESE |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | Dec 18, 2014 | SESE |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | Sep 3, 2014 | SESE |
| K141614 | MAGELLAN ROBOTIC SYSTEM | Hansen Medical | Aug 7, 2014 | SESE |
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | Hanson Medical, Inc. | Aug 5, 2014 | SESE |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | Sep 27, 2013 | SESE |
| K122488 | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | Catheter Robotics, Inc. | Nov 20, 2012 | SESE |
| K120834 | 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
