510(k) Report

Devices descending from K190910

2 later devices reach PrisMax System Version 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+1K193482PrisMax System Version 3Baxter Healthcare Corporation202002