DXX · Class II · 21 CFR 870.1290

FDA Product Code DXX: System, Catheter Control, Steerable

Leading manufacturers include Stereotaxis, Inc., Hansen Medical, Inc. and Corindus, Inc..

34
Total
34
Cleared
162d
Avg days
1990
Since
34 devices
25–34 of 34
Cleared Sep 10, 2009
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
K091808
Hansen Medical, Inc.
Cardiovascular · 84d
Cleared May 07, 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
K090365
Hansen Medical, Inc.
Cardiovascular · 83d
Cleared Jun 30, 2008
SENSEI CATHETER CONTROL SYSTEM
K073225
Hansen Medical, Inc.
Cardiovascular · 228d
Cleared Nov 14, 2007
ODYSSEY WORKSTATION
K072371
Stereotaxis, Inc.
Cardiovascular · 83d
Cleared May 02, 2007
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
K052480
Hansen Medical, Inc.
Cardiovascular · 600d
Cleared May 05, 2006
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05
K051760
Stereotaxis, Inc.
Cardiovascular · 310d
Cleared Jul 01, 2004
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500
K032937
Stereotaxis, Inc.
Cardiovascular · 283d
Cleared Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555
Stereotaxis, Inc.
Cardiovascular · 247d
Cleared May 26, 1993
CRI ELECTRONIC CONTROL SYSTEM
K924125
Catheter Research C/O Burditt, Bowles & Radzius
Cardiovascular · 282d
Cleared Dec 17, 1990
CRI STEERABLE CATHETER CONTROL SYSTEM
K904787
Catheter Research C/O Burditt, Bowles & Radzius
Cardiovascular · 55d