510(k) Report

Devices descending from K082815

10 later devices reach Well Lead Silicone and Latex Foley Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.20241—
+1K173657Radiance (TM) Clear Sharklet (R) Silicone Foley CatheterCook Incorporated20180—
+1K142635Medline Silicone Foley CatheterMedline Industries, Inc.201511
+1K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+1K091516Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd.20091—
+1K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+2K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.20250—
+2K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLC20240—
+2K202134Well Lead All Silicone Foley Catheter with Temperature SensorWell Lead Medical Co., Ltd.20210—
+2K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—