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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, catheter
Regulation Description Catheter cannula.
Product CodeDQR
Regulation Number 870.1300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DRAVON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 36
Other (for use when an appropriate device code cannot be identified) 26
Collapse 4
Break 3
Unraveled material 2
Detachment of device component 2
Particulates 2
Malfunction 2
Device, removal of (non-implant) 1
Material integrity issue 1
Device, or device fragments remain in patient 1
Air leak 1
Balloon burst 1
Balloon leak(s) 1
Disconnection 1
Explanted 1
Fracture 1
Kinked 1
Leak 1
Material perforation 1
Defective component 1
Shunts, failure of 1
Source, detachment from 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Total Device Problems 94

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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