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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device connector, airway (extension)
Regulation Description Airway connector.
Product CodeBZA
Regulation Number 868.5810
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CATHETER RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MONAGHAN MEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1
NEOTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SOUTHMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Air leak 9
Crack 8
Break 6
Detachment of device component 5
Fitting problem 5
Occlusion within device 4
Disconnection 3
Leak 2
Material separation 2
Connection issue 1
Detachment of device or device component 1
Monitor failure 1
Pumping stopped 1
Material rupture 1
Total Device Problems 49

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

Recalls
Manufacturer Recall Class Date Posted
1 King Systems Corp. II Apr-01-2015
2 Telefelx Medical II Jan-15-2010
3 Teleflex Medical II Sep-16-2009

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