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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 accessories, catheter, g-u
Regulation Description Urological catheter and accessories.
Product CodeKNY
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
LEOMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
PROMEPLA SAM
  SUBSTANTIALLY EQUIVALENT 2
SOLACE THERAPEUTICS INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 41
Tip 12
Insulation 3
Adverse Event Without Identified Device or Use Problem 3
Split 2
Material Integrity Problem 1
Inflation Problem 1
Peeled / Delaminated 1
Detachment Of Device Component 1
Packaging Problem 1
Device Operates Differently Than Expected 1
Material Fragmentation 1
Material Frayed 1
Difficult to Insert 1
Fracture 1
Problem with Sterilization 1
Total Device Problems 72


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