Company ยท US
Hansen Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2016. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 20, 2016 | K160919 | Hansen Medical Magellan Robotic Catheter 9Fr Hansen Medical, Inc. | DRA |
| Feb 1, 2016 | K153304 | Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc. | DRA |
| Aug 18, 2015 | K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components Hansen Medical, Inc. | DRA |
| Jul 23, 2015 | K151730 | Magellan Robotic System Hansen Medical, Inc. | DXX |
| Jul 1, 2015 | K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr Hansen Medical, Inc. | DXX |
| Aug 7, 2014 | K141614 | MAGELLAN ROBOTIC SYSTEM Hansen Medical | DXX |
| Feb 7, 2014 | K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT Hansen Medical | DRA |
| Sep 27, 2013 | K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR Hansen Medical, Inc. | DXX |
| Aug 29, 2012 | K122275 | ARTISAN EXTEND CONTROL CATHETER Hansen Medical | DRA |
| May 29, 2012 | K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER Hansen Medical, Inc. | DXX |
| Oct 22, 2010 | K102168 | SENSEI X ROBOTIC CATHETER SYSTEM Hansen Medical, Inc. | DXX |
| Sep 10, 2009 | K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 Hansen Medical, Inc. | DXX |
| May 7, 2009 | K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER Hansen Medical, Inc. | DXX |
| Aug 15, 2008 | K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER Hansen Medical, Inc. | DRE |
| Jun 30, 2008 | K073225 | SENSEI CATHETER CONTROL SYSTEM Hansen Medical, Inc. | DXX |
| May 2, 2007 | K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH Hansen Medical, Inc. | DXX |
| Oct 13, 2006 | K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR Hansen Medical, Inc. | DRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2016 | Hansen Medical Inc Magellan Robotic Catheter Accessory Kits,
Model number MACC 50 and MACC80.
Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a M Terminated |
DXX | K111004 K132369 +2 |
| Apr 15, 2015 | Hansen Medical Inc Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites. Terminated |
DXX | K111004 K132369 +1 |
| Dec 30, 2014 | Hansen Medical Inc Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.
Product Usage:
The Sensei X Robotic Cat Terminated |
DXX | K052480 K073225 +3 |
| Apr 6, 2010 | Hansen Medical Inc Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain Terminated |
DXX | K090365 |
| Sep 11, 2008 | Hansen Medical Inc Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and cont Terminated |
DRA | K052480 |