510(k) Report

Devices descending from K040658

17 later devices reach Bardex I.C. Latex Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101900Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc.20111—
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+1K082815Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments200810—
+2K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.20241—
+2K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc.20200—
+2K173657Radiance (TM) Clear Sharklet (R) Silicone Foley CatheterCook Incorporated20180—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+2K142635Medline Silicone Foley CatheterMedline Industries, Inc.201511
+2K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+2K091516Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd.20091—
+2K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+3K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.20250—
+3K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC20240—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+3K202134Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd.20210—
+3K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—