510(k) Report

Devices descending from K171671

4 later devices reach Prismaflex System 8.10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192756Aquadex FlexFlow System 2.0Chf Solutions, Inc.20200Class I
+1K190910PrisMax System Version 2Baxter Healthcare Corp201925
+2K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+2K193482PrisMax System Version 3Baxter Healthcare Corporation202002