• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Air leak 12
Leak 10
Inflation issue 6
Kinked 5
Suction issue 4
Mislabeled 4
Foreign material 2
Balloon leak(s) 2
Bent 2
Fitting problem 2
Other (for use when an appropriate device code cannot be identified) 2
Connection issue 2
Dislodged or dislocated 2
No Known Device Problem 2
Pressure issue 2
Scratched material 1
Device markings issue 1
Difficult to advance 1
Unknown (for use when the device problem is not known) 1
Device Issue 1
Component or accessory incompatibility 1
Break 1
Component(s), broken 1
Detachment of device component 1
Deflation issue 1
Disconnection 1
Fracture 1
Material fragmentation 1
Hole in material 1
Occlusion within device 1
Material rupture 1
Material separation 1
Device inoperable 1
Total Device Problems 77

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

Recalls
Manufacturer Recall Class Date Posted
1 Teleflex Medical I Aug-20-2015

-
-