FDA Product Code
FDA Product Code DXX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1290
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262744 | GenesisX RMN | Stereotaxis, Inc. | 2026-08-27 | Special | PDF ↗ |
| K251792 | Stereotaxis GenesisX RMN with Navigant Workstation (NWS) | Stereotaxis, Inc. | 2025-11-06 | Traditional | PDF ↗ |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS) | Microbot Medical , Ltd. | 2025-09-04 | Traditional | PDF ↗ |
| K221464 | CorPath GRX System | Corindus, Inc. | 2022-07-27 | Special | PDF ↗ |
| K202275 | CorPath GRX System | Corindus, Inc. | 2020-12-11 | Traditional | PDF ↗ |
| K180517 | CorPath GRX System | Corindus, Inc. | 2018-03-29 | Special | PDF ↗ |
| K173806 | CorPath GRX System | Corindus, Inc. | 2018-03-01 | Traditional | PDF ↗ |
| K173288 | CorPath GRX System | Corindus, Inc. | 2018-02-15 | Traditional | PDF ↗ |
| K160121 | CorPath GRX System | Corindus, Inc. | 2016-10-27 | Traditional | PDF ↗ |
| K152999 | CorPath 200 System | Corindus, Inc. | 2016-03-18 | Traditional | PDF ↗ |
| K150892 | CorPath 200 System | Corindus, Inc. | 2015-10-02 | Traditional | PDF ↗ |
| K151730 | Magellan Robotic System | Hansen Medical, Inc. | 2015-07-23 | Special | PDF ↗ |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | 2015-07-01 | Traditional | PDF ↗ |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Stereotaxis, Inc. | 2015-06-17 | Traditional | PDF ↗ |
| K141530 | VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS | Stereotaxis, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Stereotaxis, Inc. | 2014-09-03 | Traditional | PDF ↗ |
| K141614 | MAGELLAN ROBOTIC SYSTEM | Hansen Medical | 2014-08-07 | Traditional | PDF ↗ |
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM | Hanson Medical, Inc. | 2014-08-05 | Special | PDF ↗ |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | Hansen Medical, Inc. | 2013-09-27 | Special | PDF ↗ |
| K122488 | AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES | Catheter Robotics, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K120834 | CORPATH 200 SYSTEM | Corindus, Inc. | 2012-07-19 | Traditional | PDF ↗ |
| K113628 | AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES | Catheter Robotics, Inc. | 2012-06-12 | Traditional | PDF ↗ |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | Hansen Medical, Inc. | 2012-05-29 | Traditional | PDF ↗ |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | Hansen Medical, Inc. | 2010-10-22 | Special | PDF ↗ |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | Hansen Medical, Inc. | 2009-09-10 | Special | PDF ↗ |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | Hansen Medical, Inc. | 2009-05-07 | Special | PDF ↗ |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | Hansen Medical, Inc. | 2008-06-30 | Traditional | PDF ↗ |
| K072371 | ODYSSEY WORKSTATION | Stereotaxis, Inc. | 2007-11-14 | Traditional | PDF ↗ |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH | Hansen Medical, Inc. | 2007-05-02 | Traditional | PDF ↗ |
| K051760 | NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 | Stereotaxis, Inc. | 2006-05-05 | Traditional | PDF ↗ |
| K032937 | NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 | Stereotaxis, Inc. | 2004-07-01 | Traditional | PDF ↗ |
| K021555 | STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM | Stereotaxis, Inc. | 2003-01-15 | Traditional | PDF ↗ |
| K924125 | CRI ELECTRONIC CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1993-05-26 | Traditional | PDF ↗ |
| K904787 | CRI STEERABLE CATHETER CONTROL SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1990-12-17 | Traditional | PDF ↗ |
Product code DXX · Class II · Cardiovascular. Data: openFDA.