510(k) Report

Devices descending from K002868

12 later devices reach Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.20140—
+1K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+1K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+1K090262Percucath Urinary CatheterPercuvision, LLC20091—
+1K070558Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley CathetersC.R. Bard, Inc.20072—
+1K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.200761
+2K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—
+2K110214Directvision Catheter, UncoatedPercuvision20110—
+2K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+3K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+4K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+5K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—