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510(k) K052480

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH by Hansen Medical, Inc. — Product Code DXX

Clearance Details

Decision
SESU ()
Decision Date
May 2, 2007
Date Received
September 9, 2005
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, Inc.

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  • 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)

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  • K173288 — CorPath GRX System (February 15, 2018)
  • K160121 — CorPath GRX System (October 27, 2016)
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  • K150892 — CorPath 200 System (October 2, 2015)