510(k) Report

Devices descending from K000723

11 later devices reach Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201702
+1K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp.201323
+1K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.200761
+1K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp.200403
+2K150345Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201512
+2K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.20140—
+2K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094—
+3K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.20172—
+3K101824Amsure 3-Way Hydrophilic Latex Foley CatheterAmsino International, Inc.20100—
+4K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.20231—
+5K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.20260—