510(k) Report

Devices descending from K111702

2 later devices reach Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.20141—
+2K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160—