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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, assisted reproduction
Regulation Description Assisted reproduction catheters.
Product CodeMQF
Regulation Number 884.6110
Device Class 2


Premarket Reviews
ManufacturerDecision
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
GYNETICS MEDICAL PRODUCTS NV
  SUBSTANTIALLY EQUIVALENT 2
MEDGYN
  SUBSTANTIALLY EQUIVALENT 1
NONE
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SWEMED LAB INTERNATIONAL AB
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 4
Difficult to advance 2
Difficult to position 1
Other (for use when an appropriate device code cannot be identified) 1
Total Device Problems 8

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 1 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fertility Technology Resources, Inc. II Jan-19-2008
2 Smiths Medical ASD, Inc. II May-03-2013

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