Panels › Cardiovascular › Product code DXX · Class 2
System, Catheter Control, Steerable
Regulation 870.1290
2510(k)s in 12 months (34 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in DXX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hansen Medical | 10 | 4 |
| Corindus, Inc. | 9 | 0 |
| Stereotaxis, Inc. | 9 | 0 |
| Catheter Research C/O Burditt, Bowles & Radzius | 2 | 0 |
| Catheter Robotics, Inc. | 2 | 0 |
| Hanson Medical, Inc. | 1 | 0 |
| Microbot Medical , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K262744 | GenesisX RMN Stereotaxis, Inc. | DXX |
| Nov 6, 2025 | K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) Stereotaxis, Inc. | DXX |
| Sep 4, 2025 | K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) Microbot Medical , Ltd., IL | DXX |
| Jul 27, 2022 | K221464 | CorPath GRX System Corindus, Inc. | DXX |
| Dec 11, 2020 | K202275 | CorPath GRX System Corindus, Inc. | DXX |
| Mar 29, 2018 | K180517 | CorPath GRX System Corindus, Inc. | DXX |
| Mar 1, 2018 | K173806 | CorPath GRX System Corindus, Inc. | DXX |
| Feb 15, 2018 | K173288 | CorPath GRX System Corindus, Inc. | DXX |
| Oct 27, 2016 | K160121 | CorPath GRX System Corindus, Inc. | DXX |
| Mar 18, 2016 | K152999 | CorPath 200 System Corindus, Inc. | DXX |
| Oct 2, 2015 | K150892 | CorPath 200 System Corindus, Inc. | DXX |
| Jul 23, 2015 | K151730 | Magellan Robotic System Hansen Medical, Inc. | DXX |
| Jul 1, 2015 | K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr Hansen Medical, Inc. | DXX |
| Jun 17, 2015 | K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono Stereotaxis, Inc. | DXX |
| Dec 18, 2014 | K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS Stereotaxis, Inc. | DXX |
| Sep 3, 2014 | K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO Stereotaxis, Inc. | DXX |
| Aug 7, 2014 | K141614 | MAGELLAN ROBOTIC SYSTEM Hansen Medical | DXX |
| Aug 5, 2014 | K141822 | SENSEI X ROBOTIC CATHETER SYSTEM Hanson Medical, Inc. | DXX |
| Sep 27, 2013 | K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR Hansen Medical, Inc. | DXX |
| Nov 20, 2012 | K122488 | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES Catheter Robotics, Inc. | DXX |
| Jul 19, 2012 | K120834 | CORPATH 200 SYSTEM Corindus, Inc. | DXX |
| Jun 12, 2012 | K113628 | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES Catheter Robotics, Inc. | DXX |
| May 29, 2012 | K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER Hansen Medical, Inc. | DXX |
| Oct 22, 2010 | K102168 | SENSEI X ROBOTIC CATHETER SYSTEM Hansen Medical, Inc. | DXX |
| Sep 10, 2009 | K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 Hansen Medical, Inc. | DXX |
| May 7, 2009 | K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER Hansen Medical, Inc. | DXX |
| Jun 30, 2008 | K073225 | SENSEI CATHETER CONTROL SYSTEM Hansen Medical, Inc. | DXX |
| Nov 14, 2007 | K072371 | ODYSSEY WORKSTATION Stereotaxis, Inc. | DXX |
| May 2, 2007 | K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH Hansen Medical, Inc. | DXX |
| May 5, 2006 | K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 Stereotaxis, Inc. | DXX |
| Jul 1, 2004 | K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 Stereotaxis, Inc. | DXX |
| Jan 15, 2003 | K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM Stereotaxis, Inc. | DXX |
| May 26, 1993 | K924125 | CRI ELECTRONIC CONTROL SYSTEM Catheter Research C/O Burditt, Bowles & Radzius | DXX |
| Dec 17, 1990 | K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM Catheter Research C/O Burditt, Bowles & Radzius | DXX |
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