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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device arterial blood sampling kit
Regulation Description Arterial blood sampling kit.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeCBT
Regulation Number 868.1100
Device Class 1


Premarket Reviews
ManufacturerDecision
CURRIE MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 8
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tube(s), buckling of 16
Detachment of device component 13
Disconnection 11
Difficult or delayed activation 5
Incorrect display 4
Leak 4
Break 2
Device operates differently than expected 2
Defective item 1
Detachment of device or device component 1
Malfunction 1
High Readings 1
Failure to advance 1
Loose or intermittent connection 1
Needle, unsheathed 1
Device, or device fragments remain in patient 1
Valve(s), sticking 1
Material fragmentation 1
Total Device Problems 67

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

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health II Sep-02-2016
2 Smiths Medical Asd Inc III Jan-31-2008
3 Vyaire Medical II Aug-28-2017
4 Westmed Inc II Oct-20-2012

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