510(k) Report

Devices descending from K180615

2 later devices reach AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192150AMICUS Separator SystemFresenius Kabi AG20191—
+2K200530AMICUS Separator SystemFresenius Kabi AG20200—