Medical Device Manufacturer · US , Mountain View , CA

Hansen Medical, Inc. - FDA 510(k) Cleared Devices

14 submissions · 10 cleared · Since 2006
14
Total
10
Cleared
0
Denied

Hansen Medical, Inc. has 10 FDA 510(k) cleared cardiovascular devices. Based in Mountain View, US.

Historical record: 10 cleared submissions from 2006 to 2016.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Hansen Medical, Inc.

14 devices
1-14 of 14
Cleared Sep 20, 2016
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · DRA
Cardiovascular · 169d
Cleared Feb 01, 2016
Hansen Medical Magellan Robotic Catheter eKit
K153304 · DRA
Cardiovascular · 77d
Cleared Aug 18, 2015
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
K151463 · DRA
Cardiovascular · 78d
Cleared Jul 23, 2015
Magellan Robotic System
K151730 · DXX
Cardiovascular · 27d
Cleared Jul 01, 2015
Magellan Robotic System, Magellan Robotic Catheter 10Fr
K143227 · DXX
Cardiovascular · 233d
Cleared Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · DXX
Cardiovascular · 59d
Cleared May 29, 2012
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
K111004 · DXX
Cardiovascular · 414d
Cleared Oct 22, 2010
SENSEI X ROBOTIC CATHETER SYSTEM
K102168 · DXX
Cardiovascular · 81d
Cleared Sep 10, 2009
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057
K091808 · DXX
Cardiovascular · 84d
Cleared May 07, 2009
HANSEN MEDICAL ARTISAN S CONTROL CATHETER
K090365 · DXX
Cardiovascular · 83d
Cleared Aug 15, 2008
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K082075 · DRE
Cardiovascular · 23d
Cleared Jun 30, 2008
SENSEI CATHETER CONTROL SYSTEM
K073225 · DXX
Cardiovascular · 228d
Cleared May 02, 2007
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL...
K052480 · DXX
Cardiovascular · 600d
Cleared Oct 13, 2006
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
K061070 · DRC
Cardiovascular · 179d
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