Hansen Medical, Inc. - FDA 510(k) Cleared Devices
14
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hansen Medical, Inc. Cardiovascular ✕
14 devices
Cleared
Sep 20, 2016
Hansen Medical Magellan Robotic Catheter 9Fr
Cardiovascular
169d
Cleared
Feb 01, 2016
Hansen Medical Magellan Robotic Catheter eKit
Cardiovascular
77d
Cleared
Aug 18, 2015
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
Cardiovascular
78d
Cleared
Jul 23, 2015
Magellan Robotic System
Cardiovascular
27d
Cleared
Jul 01, 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
Cardiovascular
233d
Cleared
Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
Cardiovascular
59d
Cleared
May 29, 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
Cardiovascular
414d
Cleared
Oct 22, 2010
SENSEI X ROBOTIC CATHETER SYSTEM
Cardiovascular
81d
Cleared
Sep 10, 2009
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
Cardiovascular
84d
Cleared
May 07, 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
Cardiovascular
83d
Cleared
Aug 15, 2008
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
Cardiovascular
23d
Cleared
Jun 30, 2008
SENSEI CATHETER CONTROL SYSTEM
Cardiovascular
228d
Cleared
May 02, 2007
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL...
Cardiovascular
600d
Cleared
Oct 13, 2006
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
Cardiovascular
179d