FDA 510(k) Applications Submitted by Hansen Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K073225 |
11/15/2007 |
SENSEI CATHETER CONTROL SYSTEM |
HANSEN MEDICAL, INC. |
| K151463 |
06/01/2015 |
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components |
HANSEN MEDICAL, INC. |
| K132369 |
07/30/2013 |
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR |
HANSEN MEDICAL, INC. |
| K090365 |
02/13/2009 |
HANSEN MEDICAL ARTISAN S CONTROL CATHETER |
HANSEN MEDICAL, INC. |
| K111004 |
04/11/2011 |
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER |
HANSEN MEDICAL, INC. |
| K091808 |
06/18/2009 |
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 |
HANSEN MEDICAL, INC. |
| K082075 |
07/23/2008 |
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER |
HANSEN MEDICAL, INC. |
| K102168 |
08/02/2010 |
SENSEI X ROBOTIC CATHETER SYSTEM |
HANSEN MEDICAL, INC. |
| K160919 |
04/04/2016 |
Hansen Medical Magellan Robotic Catheter 9Fr |
HANSEN MEDICAL, INC. |
| K153304 |
11/16/2015 |
Hansen Medical Magellan Robotic Catheter eKit |
Hansen Medical, Inc. |
| K061070 |
04/17/2006 |
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR |
HANSEN MEDICAL, INC. |
| K052480 |
09/09/2005 |
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH |
HANSEN MEDICAL, INC. |
| K151730 |
06/26/2015 |
Magellan Robotic System |
HANSEN MEDICAL, INC. |
| K143227 |
11/10/2014 |
Magellan Robotic System, Magellan Robotic Catheter 10Fr |
HANSEN MEDICAL, INC. |
|
|
