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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
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 102
Obstruction within device 79
No Known Device Problem 50
Break 29
Packaging issue 19
Tip breakage 19
Other (for use when an appropriate device code cannot be identified) 19
Fracture 18
Foreign material present in device 17
Detachment of device component 15
Unknown (for use when the device problem is not known) 13
Stretched 11
Foreign material 10
Difficult to remove 9
Leak 9
Difficult to insert 7
Unraveled material 6
Wire(s), breakage of 6
Torn material 6
Out-of-box failure 5
Cut in material 4
Split 4
Kinked 4
Occlusion within device 4
No code available 4
Sterility 3
Prep, failure to 3
Fluid leak 3
Difficult to flush 3
Device damaged prior to use 3
No Pressure 3
Detachment of device or device component 3
Device operates differently than expected 2
Difficult to advance 2
Defective item 2
Sharp/jagged/rough/etched/scratched 2
Device, removal of (non-implant) 2
Seal, defective 2
Use of Device Issue 2
Tears, rips, holes in device, device material 2
Material frayed 2
Crack 2
Air leak 2
Migration of device or device component 2
Unsealed device packaging 2
Premature deployment 1
Retraction problem 1
Rupture, cause unknown 1
Shaft break 1
Product quality issue 1
Reflux within device 1
Device, or device fragments remain in patient 1
Mechanical issue 1
Melted 1
Membrane tear(s) 1
Balloon leak(s) 1
Blockage within device or device component 1
Component(s), broken 1
Difficult to deploy 1
Entrapment of device or device component 1
Contamination during use 1
Lead(s), breakage of 1
Material fragmentation 1
Stopcock valve, failure of 1
Failure to separate 1
Structural problem 1
Solder joint failure 1
Tear, rip or hole in device packaging 1
Catheter withdrawal interference 1
Deployment issue 1
Difficult to open or remove packaging material 1
Dislodged or dislocated 1
Device packaging compromised 1
Human-Device Interface Issue 1
Item contaminated during manufacturing or shipping 1
No Information 1
Scratched material 1
Total Device Problems 548

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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