510(k) Report

Devices descending from K980919

5 later devices reach All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190060Urethrotech UCDUrethrotech20190—
+1K132890Suprapubic Catheter and Introducer SetMediplus, Ltd.20141—
+1K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC20131—
+2K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated20180—
+2K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC20140—