510(k) Report

Devices descending from K121457

4 later devices reach Speedicath Compact Set (12 FR) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192904SpeediCath Compact SetColoplast20200—
+1K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.20162—
+2K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.20181—
+3K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc.20200—