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).
Cleared Devices (33)
| 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 |
| K113628 | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES | Catheter Robotics, Inc. | Jun 12, 2012 | SESE |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | Hansen Medical, Inc. | May 29, 2012 | SESE |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | Hansen Medical, Inc. | Oct 22, 2010 | SESE |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Hansen Medical, Inc. | Sep 10, 2009 | SESU |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | Hansen Medical, Inc. | May 7, 2009 | SESU |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | Hansen Medical, Inc. | Jun 30, 2008 | SESU |
| K072371 | ODYSSEY WORKSTATION | Stereotaxis, Inc. | Nov 14, 2007 | SESE |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | Hansen Medical, Inc. | May 2, 2007 | SESU |
| K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 | Stereotaxis, Inc. | May 5, 2006 | SESE |
| K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 | Stereotaxis, Inc. | Jul 1, 2004 | SESE |
| K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM | Stereotaxis, Inc. | Jan 15, 2003 | SESE |
| K924125 | CRI ELECTRONIC CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | May 26, 1993 | SESE |
| K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | Dec 17, 1990 | SESE |
Top Applicants
- Hansen Medical, Inc. — 9 clearances
- Corindus, Inc. — 9 clearances
- Stereotaxis, Inc. — 8 clearances
- Catheter Robotics, Inc. — 2 clearances
- Catheter Research C/O Burditt, Bowles & Radzius — 2 clearances
