510(k) Report

Devices descending from K941488

1 later device reach Devmed Double-Balloon Urological Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173533Duette 100% Silicone Dual-Balloon, Temperature-Sensing CatheterPoiesis Medical, LLC20180—