510(k) Report

Devices descending from K961706

3 later devices reach P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060734Fresenius Com.Tec Automated Cell Separator, Model 9008031; Fresenius C5L, S5L, C5L-T…Fresenius Medical Care North America20060—
+1K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd.20051—
+2K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd.20060—