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K Number
K000881
Device Name
PERFADEX SOLUTION FOR ORGAN PRESERVATION
Manufacturer
VITROLIFE SWEDEN AB
Date Cleared
2001-03-08

(353 days)

Product Code
MSB
Regulation Number
876.5880
Type
Traditional
Panel
Gastroenterology/Urology
Reference & Predicate Devices
N/A
Predicate For
K022730,K091989,K211314
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 876.5880 Isolated kidney perfusion and transport system and accessories.

(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).