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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, catheter control, steerable
Regulation Description Steerable catheter control system.
Product CodeDXX
Regulation Number 870.1290
Device Class 2


Premarket Reviews
ManufacturerDecision
CATHETER ROBOTICS INC
  SUBSTANTIALLY EQUIVALENT 2
CORINDUS INC.
  SUBSTANTIALLY EQUIVALENT 1
HANSEN MEDICAL, INC.
  SE - WITH LIMITATIONS 4
  SUBSTANTIALLY EQUIVALENT 5
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Unintended movement 21
No Known Device Problem 2
Total Device Problems 23

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 0 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hansen Medical Inc II Apr-25-2016
2 Hansen Medical Inc II Apr-15-2015
3 Hansen Medical Inc II Dec-30-2014
4 Hansen Medical Inc II Apr-06-2010

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