• 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, catheter, ureteral
Regulation Description Ureteral dilator.
Product CodeEZN
Regulation Number 876.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burst 57
Inflation issue 51
Leak 44
Balloon burst 42
Balloon rupture 26
Balloon leak(s) 25
Kinked 23
Hole in material 16
Device Issue 12
Balloon pinhole 10
Tears, rips, holes in device, device material 9
Bent 9
Deflation issue 9
Torn material 6
Failure to advance 5
Defective item 5
Material perforation 5
Break 5
Other (for use when an appropriate device code cannot be identified) 5
Material rupture 4
Difficult to remove 4
Material fragmentation 4
Device damaged prior to use 4
No Known Device Problem 3
Material separation 3
Fitting problem 3
Unknown (for use when the device problem is not known) 2
Tip breakage 2
Unsealed device packaging 2
Device packaging compromised 2
Difficult to advance 1
Material deformation 1
Defective component 1
Pressure, insufficient 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Device operates differently than expected 1
Decrease in pressure 1
Material puncture 1
Unable to obtain readings 1
Reuse 1
Source, detachment from 1
Detachment of device component 1
Device abrasion from instrument or another object 1
Mislabeled 1
Delivered as unsterile product 1
Displacement 1
False reading from device non-compliance 1
Foreign material 1
Total Device Problems 416

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-30-2008

-
-