510(k) Report

Devices descending from K070508

6 later devices reach Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.20140—
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+2K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—