510(k) Report

Devices descending from K203637

2 later devices reach SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…Well Lead Medical Co., Ltd.20250—
+1K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)Coloplast20240—