SherpaPak Lung Preservation System , SherpaPak Liver Transport System

System, Perfusion, Kidney

Pragonix Technologies

The following data is part of a premarket notification filed by Pragonix Technologies with the FDA for Sherpapak Lung Preservation System , Sherpapak Liver Transport System.

Pre-market Notification Details

Device IDK192869
510k NumberK192869
Device Name:SherpaPak Lung Preservation System , SherpaPak Liver Transport System
ClassificationSystem, Perfusion, Kidney
Applicant Pragonix Technologies Suite 408, 639 Granite Street Braintree,  MA  02184
ContactLisa Anderson
CorrespondentLeo Basta
Northstar Biomedical Associates 93 Benefit St Providence,  RI  02904
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-07
Decision Date2020-01-16

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