510(k) Report

Devices descending from K984084

11 later devices reach Bardex Lubri-Sil Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley…Pathway, LLC20203—
+1K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.20140—
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+1K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.200761
+2K2216252-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation20222—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+2K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+3K2221182-Way 100% Silicone Cleartract CatheterSilq Technologies, Corp.20221—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—
+4K2330132-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation20240—