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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device dilator, catheter, ureteral
Regulation Description Ureteral dilator.
Product CodeEZN
Regulation Number 876.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Burst Container or Vessel 41
Catheter 20
Kinked 18
Balloon 13
Leak/Splash 10
Material Rupture 8
Deflation Problem 8
Break 7
Inflation Problem 7
Device Packaging Compromised 6
Seal 6
Difficult to Remove 5
Material Puncture/Hole 5
Device Contamination with Chemical or Other Material 3
Misassembled 3
Shaft 3
Bent 3
Tip 3
Material Deformation 3
Device Slipped 3
Adverse Event Without Identified Device or Use Problem 3
Contamination /Decontamination Problem 2
Material Split, Cut or Torn 2
Guidewire 2
Use of Device Problem 2
Difficult to Advance 2
Device Operates Differently Than Expected 2
Material Separation 2
Tear, Rip or Hole in Device Packaging 2
Defective Device 1
Packaging Problem 1
Failure to Infuse 1
Torn Material 1
Deformation Due to Compressive Stress 1
Balloon rupture 1
Partial Blockage 1
Material Integrity Problem 1
Device Handling Problem 1
Unraveled Material 1
Device Dislodged or Dislocated 1
Hole In Material 1
Appropriate Term/Code Not Available 1
Unsealed Device Packaging 1
Difficult To Position 1
Physical Resistance/Sticking 1
Device Damaged Prior to Use 1
Patient-Device Incompatibility 1
Detachment of Device or Device Component 1
Total Device Problems 213


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