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510(k) K133552

MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT by Hansen Medical — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2014
Date Received
November 19, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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  • 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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