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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheal/bronchial, differential ventilation (w/wo connector)
Regulation Description Tracheal/bronchial differential ventilation tube.
Product CodeCBI
Regulation Number 868.5740
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
PULMONX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 18
Air leak 13
Inflation issue 11
Break 7
Dislodged or dislocated 6
Kinked 5
Suction issue 4
Fitting problem 4
Device operates differently than expected 4
Mislabeled 4
Device alarm system issue 3
Balloon leak(s) 2
Bent 2
Deflation issue 2
Foreign material 2
Connection issue 2
Device markings issue 2
No Known Device Problem 2
Hole in material 2
Material separation 2
Pressure issue 2
Unintended movement 1
Device inoperable 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Device Issue 1
Component or accessory incompatibility 1
Packaging issue 1
Material deformation 1
Difficult to advance 1
Fracture 1
Material fragmentation 1
Difficult to insert 1
Occlusion within device 1
Difficult to position 1
Disconnection 1
Component(s), broken 1
Detachment of device component 1
Total Device Problems 116

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Parker Medical II Mar-03-2017
2 Teleflex Medical I Aug-20-2015

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