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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, vessel, for percutaneous catheterization
Regulation Description Vessel dilator for percutaneous catheterization.
Product CodeDRE
Regulation Number 870.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ARSTASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AVALON
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOMBS MEDICAL DEVICE CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICROVENA
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 97
Obstruction within device 79
No Known Device Problem 47
Break 28
Packaging issue 19
Other (for use when an appropriate device code cannot be identified) 19
Tip breakage 19
Foreign material present in device 16
Unknown (for use when the device problem is not known) 13
Detachment of device component 12
Fracture 12
Foreign material 10
Stretched 10
Difficult to remove 9
Leak 9
Difficult to insert 7
Unraveled material 6
Wire(s), breakage of 6
Out-of-box failure 5
Torn material 5
Split 4
Kinked 4
Occlusion within device 4
Prep, failure to 3
Sterility 3
Fluid leak 3
Difficult to flush 3
Detachment of device or device component 3
No code available 3
No Pressure 3
Device damaged prior to use 3
Cut in material 3
Defective item 2
Sharp/jagged/rough/etched/scratched 2
Device, removal of (non-implant) 2
Seal, defective 2
Use of Device Issue 2
Device operates differently than expected 2
Difficult to advance 2
Air leak 2
Tears, rips, holes in device, device material 2
Unsealed device packaging 2
Premature deployment 1
Lead(s), breakage of 1
Product quality issue 1
Reflux within device 1
Device, or device fragments remain in patient 1
Retraction problem 1
Rupture, cause unknown 1
Shaft break 1
Balloon leak(s) 1
Blockage within device or device component 1
Component(s), broken 1
Contamination during use 1
Crack 1
Difficult to deploy 1
Entrapment of device or device component 1
Material frayed 1
Mechanical issue 1
Melted 1
Membrane tear(s) 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
Device packaging compromised 1
Failure to separate 1
Scratched material 1
No Information 1
Solder joint failure 1
Stopcock valve, failure of 1
Catheter withdrawal interference 1
Deployment issue 1
Structural problem 1
Tear, rip or hole in device packaging 1
Total Device Problems 520

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 2 1 0 0 0 2 2
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Mar-01-2016
2 Argon Medical Devices, Inc II Jun-02-2010
3 Argon Medical Devices, Inc III Feb-02-2010
4 Boston Scientific Corporation II Nov-21-2011
5 Cordis Corporation II Mar-15-2016
6 Galt Medical Corp II May-11-2010
7 Merit Medical Systems, Inc. II Jun-22-2015
8 Merit Medical Systems, Inc. II Dec-14-2009
9 Procedure Products, Inc. II Dec-01-2015

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