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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
INTEGRA
  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 39
Other (for use when an appropriate device code cannot be identified) 28
Deployment issue 25
Break 19
Failure to deploy 17
Collapse 4
Device Issue 4
No Known Device Problem 3
Malfunction 2
Device, removal of (non-implant) 2
Blocked connection 2
Chemical issue 2
Kinked 2
Unraveled material 2
Detachment of device component 2
Migration of device or device component 2
Particulates 2
Device, or device fragments remain in patient 1
Difficult to remove 1
Shunts, failure of 1
Size incorrect for patient 1
Source, detachment from 1
Tears, rips, holes in device, device material 1
Tip breakage 1
Uncoiled 1
Air leak 1
Balloon burst 1
Balloon leak(s) 1
Disconnection 1
Explanted 1
Fracture 1
Valve(s), failure of 1
Fitting problem 1
Leak 1
Material perforation 1
Defective component 1
Component missing 1
Wire(s), breakage of 1
Failure to separate 1
Torn material 1
No Information 1
Device handling issue 1
Material integrity issue 1
Total Device Problems 183

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

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II May-25-2013

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