510(k) Report

Devices descending from K951106

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+2K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—