510(k) Report

Devices descending from K910195

8 later devices reach Bard Hydrogel-Coated Foley Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150699Bard LubriGuard Foley CatheterC.R. Bard, Inc.20151—
+1K990500Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter…The Kendal Co.19995Class I
+2K180781Bard Vertus Foley CatheterC.R. Bard, Inc.20180—
+2K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc.20060—
+2K042110BeamcathBeampoint AB20053—
+3K140099Lighthouse Urinary CatheterSeedings Life Science Ventures, LLC20140—
+3K131655Lighthouse (TM) Urinary CatheterSeedings Life Science Ventures, LLC20131—
+3K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd.20080—