510(k) Report

Devices descending from K811078

6 later devices reach Radiation Sterilized Admin. Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142011Solution Set/Extension SetBaxter Healthcare Corporation20141—
+1K073339Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…Fenwal, Inc.20083—
+2K150860Nitroglycerin Sets with DUO-VENT SpikeBaxter Healthcare Corporation20150—
+2K111702Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus TpeFenwal, Inc.201221
+3K141019Amicus Separator System/ Amicus Seperator System;RefurbishedFenwal, Inc.20141—
+4K162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,Llc20160—