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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, double lumen female urethrographic
Regulation Description Urological catheter and accessories.
Product CodeFGH
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Deflation issue 6
Break 4
Burst 4
Leak 3
Torn material 2
Unintended movement 1
Split 1
Material Protrusion 1
Inflation issue 1
Total Device Problems 23

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