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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shunt, peritoneal
Product CodeKPM
Regulation Number 876.5955
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT - KIT 1
PLEURAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 1 1
Occlusion Within Device 1 1
Defective Component 1 1
Device Contamination with Chemical or Other Material 1 1
Mechanics Altered 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Death 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

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