510(k) Report

Devices descending from K043461

4 later devices reach Custodiol through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH202011
+1K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…S.A.L.F. Spa20170—
+1K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc.20140—
+2K241239OrganProtex HTK SolutionBridge TO Life, Ltd.20250—