FDA 510(k) Applications for Medical Device Product Code "DXX"
(System, Catheter Control, Steerable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K113628 | CATHETER ROBOTICS INC | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES | 06/12/2012 |
| K122488 | CATHETER ROBOTICS INC | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | 11/20/2012 |
| K120834 | CORINDUS INC. | CORPATH 200 SYSTEM | 07/19/2012 |
| K150892 | CORINDUS, INC. | CorPath 200 System | 10/02/2015 |
| K152999 | CORINDUS, INC. | CorPath 200 System | 03/18/2016 |
| K173288 | Corindus, Inc. | CorPath GRX System | 02/15/2018 |
| K173806 | Corindus, Inc. | CorPath GRX System | 03/01/2018 |
| K180517 | Corindus, Inc. | CorPath GRX System | 03/29/2018 |
| K202275 | Corindus, Inc. | CorPath GRX System | 12/11/2020 |
| K221464 | Corindus, Inc. | CorPath GRX System | 07/27/2022 |
| K160121 | Corindus, Inc. | CorPath GRX System | 10/27/2016 |
| K141614 | Hansen Medical | MAGELLAN ROBOTIC SYSTEM | 08/07/2014 |
| K090365 | HANSEN MEDICAL, INC. | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | 05/07/2009 |
| K052480 | HANSEN MEDICAL, INC. | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | 05/02/2007 |
| K111004 | HANSEN MEDICAL, INC. | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | 05/29/2012 |
| K151730 | HANSEN MEDICAL, INC. | Magellan Robotic System | 07/23/2015 |
| K143227 | HANSEN MEDICAL, INC. | Magellan Robotic System, Magellan Robotic Catheter 10Fr | 07/01/2015 |
| K132369 | HANSEN MEDICAL, INC. | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | 09/27/2013 |
| K073225 | HANSEN MEDICAL, INC. | SENSEI CATHETER CONTROL SYSTEM | 06/30/2008 |
| K091808 | HANSEN MEDICAL, INC. | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | 09/10/2009 |
| K102168 | HANSEN MEDICAL, INC. | SENSEI X ROBOTIC CATHETER SYSTEM | 10/22/2010 |
| K141822 | HANSON MEDICAL, INC. | SENSEI X ROBOTIC CATHETER SYSTEM | 08/05/2014 |
| K032937 | STEREOTAXIS, INC. | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 | 07/01/2004 |
| K051760 | STEREOTAXIS, INC. | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 | 05/05/2006 |
| K072371 | STEREOTAXIS, INC. | ODYSSEY WORKSTATION | 11/14/2007 |
| K021555 | STEREOTAXIS, INC. | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM | 01/15/2003 |
| K150312 | STEREOTAXIS, INC. | Vdrive system, Vdrive Duo, Vdrive with V-Sono | 06/17/2015 |
| K141530 | STEREOTAXIS, INC. | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | 12/18/2014 |
| K140804 | STEREOTAXIS, INC. | VDRIVE WITH V-LOOP/ VDRIVE DUO | 09/03/2014 |
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