• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
CARDIAC ASSIST DIV.
  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 52
Break 29
Foreign material present in device 23
Detachment of device component 22
Packaging issue 20
Fracture 20
Tip breakage 19
Other (for use when an appropriate device code cannot be identified) 19
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
Torn material 6
Wire(s), breakage of 6
Unraveled material 6
Out-of-box failure 5
Split 4
Cut in material 4
Kinked 4
Occlusion within device 4
No code available 4
Difficult to flush 3
Sterility 3
Prep, failure to 3
Device damaged prior to use 3
Fluid leak 3
Detachment of device or device component 3
Unsealed device packaging 3
No Pressure 3
Seal, defective 2
Sharp/jagged/rough/etched/scratched 2
Device, removal of (non-implant) 2
Air leak 2
Crack 2
Defective item 2
Difficult to advance 2
Migration of device or device component 2
Device operates differently than expected 2
Tears, rips, holes in device, device material 2
Use of Device Issue 2
Material frayed 2
Membrane tear(s) 1
Difficult to deploy 1
Retraction problem 1
Melted 1
Stopcock valve, failure of 1
Dislodged or dislocated 1
Deployment issue 1
Structural problem 1
Device, or device fragments remain in patient 1
Human-Device Interface Issue 1
Tear, rip or hole in device packaging 1
Product quality issue 1
Contamination during use 1
Solder joint failure 1
Scratched material 1
Entrapment of device or device component 1
Rupture, cause unknown 1
Premature deployment 1
Component(s), broken 1
No Information 1
Difficult to open or remove packaging material 1
Mechanical issue 1
Balloon leak(s) 1
Failure to separate 1
Material fragmentation 1
Catheter withdrawal interference 1
Device packaging compromised 1
Blockage within device or device component 1
Item contaminated during manufacturing or shipping 1
Lead(s), breakage of 1
Reflux within device 1
Shaft break 1
Total Device Problems 567

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

-
-