Hansen Medical Inc
FDA Regulatory Profile
Hansen Medical Inc appears in FDA public data with 3 recalls, 17 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1564-2016, Class II) was initiated on March 25, 2016. Its most recent 510(k) clearance was granted on September 20, 2016.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 17
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1564-2016 | Class II | Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hanse | March 25, 2016 |
| Z-1449-2015 | Class II | Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at | March 18, 2015 |
| Z-0896-2015 | Class II | Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clam | December 4, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | September 20, 2016 |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | February 1, 2016 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | August 18, 2015 |
| K151730 | Magellan Robotic System | July 23, 2015 |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | July 1, 2015 |
| K141614 | MAGELLAN ROBOTIC SYSTEM | August 7, 2014 |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | February 7, 2014 |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR | September 27, 2013 |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | August 29, 2012 |
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER | May 29, 2012 |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM | October 22, 2010 |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 | September 10, 2009 |
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER | May 7, 2009 |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | August 15, 2008 |
| K073225 | SENSEI CATHETER CONTROL SYSTEM | June 30, 2008 |
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETE | May 2, 2007 |
| K061070 | HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR | October 13, 2006 |