510(k) Report

Devices descending from K101900

1 later device reach Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc.20200—