510(k) Report

Devices descending from K993064

9 later devices reach Prisma CFM (Continuous Fluid Management System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070320Edwards Aquarius Hemofiltration System, Model Abm 01Edwards Lifesciences Services GmbH200711
+1K021615Baxter Accura System, Model 5M5660Baxter Healthcare Corp200283
+2K090682Edwards Aquarius System, Model GE-F098-00Edwards Lifesciences Services GmbH20090—
+2K063293Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards…Edwards Lifesciences Services GmbH20070—
+2K041005Gambro Prismaflex and Gambro Prismaflex M60 & M100 SetsGambro Renal Products200447
+3K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setBaxter Healthcare Corporation202203
+3K080519Prismaflex M150 SetGambro Renal Products, Inc.200813
+3K042938Gambro Prismaflex HF1000 and HF1400 SetsGambro Renal Products200517
+4K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—