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MSB — System And Accessories, Isolated Heart, Transport And Preservation Class II

FDA Device Classification

Classification Details

Product Code
MSB
Device Class
Class II
Regulation Number
876.5880
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222535transmedicsOCS Lung Donor Flush SetNovember 18, 2022
K211314transmedicsOCS Lung SolutionJuly 29, 2021
K190063s.a.l.fServator C SALF SolutionAugust 14, 2019
K182735paragonix technologiesParagonix SherpaPak Cardiac Transport SystemOctober 19, 2018
K180194paragonix technologiesSherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemMarch 30, 2018
K143074paragonix technologiesSherpa Pak Cardiac Transport SystemNovember 25, 2014
K133432paragonix technologiesSHERPA PAK CARDIAC TRANSPORT SYSTEMFebruary 21, 2014
K123326paragonix technologiesSHERPA PAK CARDIAC TRANSPORT SYSTEMFebruary 6, 2013
K081997vitrolife swedenPERFADEX WITH THAMOctober 9, 2008
K032794franz kohler chemieCUSTODIOLApril 5, 2004
K022730vitrolifePERFADEX SOLUTION FOR LUNG PRESERVATIONOctober 27, 2003
K000881vitrolife swedenPERFADEX SOLUTION FOR ORGAN PRESERVATIONMarch 8, 2001
K991594sangstat medicalCELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTSAugust 5, 1999