510(k) Report

Devices descending from K980870

3 later devices reach Rusch Silicone Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212151FLUME catheterThe Flume Catheter Company, Ltd.20211—
+1K062112Sunmed Foley CathetersSunmed, Inc.20070—
+2K231101Flume CatheterFlume Catheter Company, Ltd.20230—