510(k) Report

Devices descending from K013276

2 later devices reach All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) through their predicates, nearest generation first.

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