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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, urethral
Regulation Description Urethral dilator.
Product CodeKOE
Regulation Number 876.5520
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
ATRION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Material separation 6
Flaked 4
Balloon rupture 2
Break 2
Tear, rip or hole in device packaging 2
Balloon pinhole 1
Material integrity issue 1
Component(s), broken 1
Component falling 1
Product quality issue 1
Use of Device Issue 1
Other (for use when an appropriate device code cannot be identified) 1
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 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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