Medical Device Manufacturer · US , Mountain View , CA

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

14 submissions · 10 cleared · Since 2006

Recent clearances: Hansen Medical Magellan Robotic Catheter 9Fr, Hansen Medical Magellan Robotic Catheter eKit, Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components

View 14 510(k) Devices ↓

14

Total

10

Cleared

0

Denied

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

14 devices

1-12 of 14

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