FDA 510(k) Applications for Medical Device Product Code "DXX"
(System, Catheter Control, Steerable)

FDA 510(k) Number Applicant Device Name Decision Date
K924125 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS CRI ELECTRONIC CONTROL SYSTEM 05/26/1993
K904787 CATHETER RESEARCH C/O BURDITT, BOWLES & RADZIUS CRI STEERABLE CATHETER CONTROL SYSTEM 12/17/1990
K122488 CATHETER ROBOTICS INC AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES 11/20/2012
K113628 CATHETER ROBOTICS INC AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES 06/12/2012
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
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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