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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, fixation, tracheal tube
Regulation Description Tracheal tube fixation device.
Product CodeCBH
Regulation Number 868.5770
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 1
DALE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ERGOMED
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
Ventlab Corporation
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Normal 13
Loss of or failure to bond 4
Increase in pressure 2
Material erosion 2
Device abrasion from instrument or another object 2
Method, improper/incorrect 1
Break 1
Component(s), broken 1
Dislodged 1
Disposable 1
Total Device Problems 28

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 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Dale Medical Products, Inc. II Jan-11-2008

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