510(k) Report

Devices descending from K192034

3 later devices reach HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2216252-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation20222—
+2K2221182-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp.20221—
+3K2330132-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation20240—