FDA 510(k) Applications for Medical Device Product Code: MSB (System&Accessories,Isolated Heart,Transport&Preservation)

FDA 510(k) Applications for Medical Device Product Code "MSB"
(System&Accessories,Isolated Heart,Transport&Preservation)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K032794	DR. FRANZ KOHLER CHEMIE GMBH	CUSTODIOL	04/05/2004
K182735	Paragonix Technologies	Paragonix SherpaPak Cardiac Transport System	10/19/2018
K143074	PARAGONIX TECHNOLOGIES, INC.	Sherpa Pak Cardiac Transport System	11/25/2014
K123326	PARAGONIX TECHNOLOGIES, INC.	SHERPA PAK CARDIAC TRANSPORT SYSTEM	02/06/2013
K133432	PARAGONIX TECHNOLOGIES, INC.	SHERPA PAK CARDIAC TRANSPORT SYSTEM	02/21/2014
K180194	Paragonix Technologies, Inc.	SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System	03/30/2018
K190063	S.A.L.F. Spa	Servator C SALF Solution	08/14/2019
K991594	SANGSTAT MEDICAL CORP.	CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS	08/05/1999
K222535	TransMedics, Inc.	OCS Lung Donor Flush Set	11/18/2022
K211314	TransMedics, Inc.	OCS Lung Solution	07/29/2021
K022730	VITROLIFE AB	PERFADEX SOLUTION FOR LUNG PRESERVATION	10/27/2003
K000881	VITROLIFE SWEDEN AB	PERFADEX SOLUTION FOR ORGAN PRESERVATION	03/08/2001
K081997	VITROLIFE SWEDEN AB	PERFADEX WITH THAM	10/09/2008