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510(k) K141614

MAGELLAN ROBOTIC SYSTEM by Hansen Medical — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
June 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type

Other clearances by Hansen Medical

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  • K151730 — Magellan Robotic System (July 23, 2015)
  • K143227 — Magellan Robotic System, Magellan Robotic Catheter 10Fr (July 1, 2015)
  • K133552 — MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR (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)

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