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Hansen Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
17
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1564-2016Class IIMagellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The HanseMarch 25, 2016
Z-1449-2015Class IIMagellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at March 18, 2015
Z-0896-2015Class IISensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamDecember 4, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K160919Hansen Medical Magellan Robotic Catheter 9FrSeptember 20, 2016
K153304Hansen Medical Magellan Robotic Catheter eKitFebruary 1, 2016
K151463Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsAugust 18, 2015
K151730Magellan Robotic SystemJuly 23, 2015
K143227Magellan Robotic System, Magellan Robotic Catheter 10FrJuly 1, 2015
K141614MAGELLAN ROBOTIC SYSTEMAugust 7, 2014
K133552MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KITFebruary 7, 2014
K132369MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRSeptember 27, 2013
K122275ARTISAN EXTEND CONTROL CATHETERAugust 29, 2012
K111004HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERMay 29, 2012
K102168SENSEI X ROBOTIC CATHETER SYSTEMOctober 22, 2010
K091808SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057September 10, 2009
K090365HANSEN MEDICAL ARTISAN S CONTROL CATHETERMay 7, 2009
K082075HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETERAugust 15, 2008
K073225SENSEI CATHETER CONTROL SYSTEMJune 30, 2008
K052480HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETEMay 2, 2007
K061070HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOROctober 13, 2006