510(k) Report

Devices descending from K110491

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.20181—
+2K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.20210—