510(k) Report

Devices descending from K945543

2 later devices reach Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013256BI-3M Needle-Free Injector SystemFelton International, Inc.20011—
+2K041280Human Subcutaneous Injector, Model Hsi 500Felton International, Inc.20040—