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510(k) Data Aggregation
K Number
K243998Device Name
DCX Disposable Cassette (DCX)
Manufacturer
Institut Geroges Lopez
Date Cleared
2025-04-25
(120 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
Institut Geroges Lopez
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DCX Disposable Cassette, as part of the Kidney Perfusion System, is intended to be used for the pulsatile hypothermic machine perfusion (RM4 Kidney Perfusion System) of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
Device Description
The DCX Disposable Cassette, provides a sterile fluid pathway, houses and protects the kidneys during perfusion and it has a gravity flow system which allows circulation of perfusate through the kidneys.
The kidneys are placed in an organ chamber filled with perfusate. The perfusate flows from the organ chamber to the pumphead. Then, it is pumped through the heat exchanger to the bubble trap where it is delivered to the cannulated kidney(s). The perfusate then returns to the organ chamber via the kidney vein to repeat the perfusion cycle.
The cassette can provide circulation of perfusate to one or two kidneys, attached individually or in bloc.
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