Product code DXX
- Device name
- System, Catheter Control, Steerable
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1290
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251792 | Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) | Stereotaxis, Inc. | 2025-11-06 |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | 2025-09-04 |
| K221464 | CorPath GRX System | Corindus, Inc. | 2022-07-27 |
| K202275 | CorPath GRX System | Corindus, Inc. | 2020-12-11 |
| K180517 | CorPath GRX System | Corindus, Inc. | 2018-03-29 |
| K173806 | CorPath GRX System | Corindus, Inc. | 2018-03-01 |
| K173288 | CorPath GRX System | Corindus, Inc. | 2018-02-15 |
| K160121 | CorPath GRX System | Corindus, Inc. | 2016-10-27 |
| K152999 | CorPath 200 System | Corindus, Inc. | 2016-03-18 |
| K150892 | CorPath 200 System | Corindus, Inc. | 2015-10-02 |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | 2015-07-23 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | 2015-07-01 |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015-06-17 |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | 2014-12-18 |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | 2014-09-03 |
| K141614 | MAGELLAN ROBOTIC SYSTEM | Hansen Medical | 2014-08-07 |
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | Hanson Medical, Inc. | 2014-08-05 |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | 2013-09-27 |
| K122488 | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | Catheter Robotics, Inc. | 2012-11-20 |
| K120834 | CORPATH 200 SYSTEM | Corindus, Inc. | 2012-07-19 |
| K113628 | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES | Catheter Robotics, Inc. | 2012-06-12 |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | Hansen Medical, Inc. | 2012-05-29 |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | Hansen Medical, Inc. | 2010-10-22 |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Hansen Medical, Inc. | 2009-09-10 |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | Hansen Medical, Inc. | 2009-05-07 |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | Hansen Medical, Inc. | 2008-06-30 |
| K072371 | ODYSSEY WORKSTATION | Stereotaxis, Inc. | 2007-11-14 |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | Hansen Medical, Inc. | 2007-05-02 |
| K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 | Stereotaxis, Inc. | 2006-05-05 |
| K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 | Stereotaxis, Inc. | 2004-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M58800101400010 | GenesisX | Stereotaxis, Inc. | 2026-01-09 |
| 07290019564003 | LIBERTY Endovascular Robotic System | MICROBOT MEDICAL LTD | 2025-11-18 |
| 07290019564058 | LIBERTY Endovascular Robotic System - robot | MICROBOT MEDICAL LTD | 2025-11-18 |
| 07290019564102 | LIBERTY Endovascular Robotic System - arm | MICROBOT MEDICAL LTD | 2025-11-18 |
| 00816280023185 | CorPath GRX Cassette Duo | CORINDUS, INC. | 2022-08-08 |
| 00816280023192 | CorPath GRX Cassette Duo | Corindus, Inc. | 2022-08-08 |
| 00815671020246 | Sensei® | HANSEN MEDICAL, INC. | 2016-09-30 |
| 00815671020321 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-30 |
| 00815671020314 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-30 |
| 00815671020284 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-30 |
| 00815671020260 | Sensei® | HANSEN MEDICAL, INC. | 2016-09-30 |
| 00816280022027 | CorPath 200 Articulated Arm | Corindus, Inc. | 2016-09-24 |
| 00816280022010 | CorPath 200 Control Console | Corindus, Inc. | 2016-09-24 |
| 00815671020215 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020048 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020208 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020147 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020130 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020079 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020062 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 00815671020055 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| 10815671020007 | Artisan® | HANSEN MEDICAL, INC. | 2016-09-23 |
| 10815671020083 | Magellan™ | HANSEN MEDICAL, INC. | 2016-09-23 |
| M58800101005611 | Vdrive Drape | Stereotaxis, Inc. | 2016-08-01 |
| M58800100701020 | Odyssey | Stereotaxis, Inc. | 2016-08-01 |
| M58800100230720 | Vdrive System | Stereotaxis, Inc. | 2016-08-01 |
| M58800100230710 | Vdrive System | Stereotaxis, Inc. | 2016-08-01 |
| M58800100246910 | V-Sono Intracardiac Echo Manipulator | Stereotaxis, Inc. | 2016-05-02 |
| M58800100245210 | V-Loop Variable Loop Catheter Manipulator | Stereotaxis, Inc. | 2016-05-02 |
| M58800100242210 | V-CAS Catheter Advancement System | Stereotaxis, Inc. | 2016-05-02 |