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510(k) Data Aggregation
K Number
K192869Device Name
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
Manufacturer
Pragonix Technologies
Date Cleared
2020-01-16
(101 days)
Product Code
KDN
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
Pragonix Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paragonix SherpaPak™ Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs.
The intended organ storage time for the Paragonix SherpaPak™ Lung Preservation System is up to 8 hours.
Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Note: Partial lungs can be transported via SherpaPak™ LPS by packaging lungs per institutional protocol and UNOS guidelines.
The Paragonix SherpaPak™ Liver Transport System is intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the livers.
The intended organ storage time for the Paragonix SherpaPak™ Liver Transport System is up to 15 hours.
Donor livers exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplance with accepted clinical guidelines and in the best medical interest of the intended recipient.
Device Description
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