510(k) Report

Devices descending from K073339

3 later devices reach Blood Component Recipient Set with Standard Size Filter and Infusion Set with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc.201221
+2K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.20141—
+3K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160—