510(k) Report

Devices descending from K991594

9 later devices reach Celsior Cold Flush, Storage and Transport Solution for Hearts through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190063Servator C SALF SolutionS.A.L.F. Spa20190—
+1K143074Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc.20140—
+1K133432Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc.20143—
+1K123326Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc.20136—
+1K032794CustodiolDr. Franz Kohler Chemie GmbH20041—
+2K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc.20181—
+2K133694Sherpa Pak TransporterParagonix Technologies, Inc.20143—
+3K261913X°Port Heart Preservation SystemTraferox Technologies, Inc.20260—
+3K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc.20140—