510(k) Report

Devices descending from K001156

2 later devices reach Phoenix Hemodialysis Delivery System, Gambro Cartridge for Hemodialysis Blood… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation20231Class I
+2K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC20250—