510(k) Report

Devices descending from K070558

2 later devices reach Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.20091—
+2K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180—