510(k) Report

Devices descending from K130804

4 later devices reach Uromax Ultra Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.20250—
+1K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.20200—
+1K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.20190—
+1K132181Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America20130—