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510(k) K160919

Hansen Medical Magellan Robotic Catheter 9Fr by Hansen Medical, Inc. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2016
Date Received
April 4, 2016
Clearance Type
Traditional
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

Other clearances by Hansen Medical, Inc.

  • 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 (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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