510(k) Report

Devices descending from K070643

7 later devices reach Phoenix Hemodialysis Delivery System, Version 3.35 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103832Phoenix Hemodialysis Delivery SystemGambro Renal Products, Inc.201142
+1K103242Redsense-Alarm Unit and SensorRedsense Medical AB20111—
+2K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryBaxter Healthcare Corportation20213—
+2K130554Redsense Alarm SystemRedsense Medical AB20130—
+3K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation20231Class I
+3K211035U9000 Plus UltrafilterBaxter Healthcare Corporation20210—
+4K250508AK 98 Dialysis Machine (955607)Vantive US Healthcare, LLC20250—