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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, upper urinary tract
Regulation Description Urological catheter and accessories.
Product CodeEYC
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Source, detachment from 1
Defective item 1
No Information 1
Inflation issue 1
Infusion or flow issue 1
Total Device Problems 5

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