510(k) Report

Devices descending from K131516

7 later devices reach Prismaflex System 7.10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171671Prismaflex System 8.10Baxter Healthcare Corporation20184—
+1K163530PrisMax Control UnitBaxter Healthcare Corp20174—
+2K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—
+2K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I
+2K190910PrisMax System Version 2Baxter Healthcare Corp201925
+3K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+3K193482PrisMax System Version 3Baxter Healthcare Corporation202002