510(k) Report

Devices descending from K072808

12 later devices reach Speedicath Compact through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…Coloplast20222—
+1K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.20162—
+1K150935SpeediCath Compact EveColoplast A/S20150—
+1K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp.201323
+1K121457Speedicath Compact Set (12 FR)Coloplast Corp.20124—
+2K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…Well Lead Medical Co., Ltd.20250—
+2K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)Coloplast20240—
+2K192904SpeediCath Compact SetColoplast20200—
+2K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.20181—
+2K150345Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201512
+3K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc.20200—
+3K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201702