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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, perfusion, kidney
Regulation Description Isolated kidney perfusion and transport system and accessories.
Product CodeKDN
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
BRIDGE TO LIFE
  SUBSTANTIALLY EQUIVALENT 3
BRIDGE TO LIFE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT GEORGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT GEROGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 1
PARAGONIX TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PARAGONIX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 2
TRAFEROX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
XVIVO PERFUSION AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2025 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 2 2
Fluid/Blood Leak 2 2
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Premature Discharge of Battery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bridge to Life Ltd II Jul-22-2025
2 Waters Medical Systems LLC II Apr-27-2022
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