510(k) Report

Devices descending from K980795

5 later devices reach Urological Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130804Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation201341
+2K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.20250—
+2K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.20200—
+2K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.20190—
+2K132181Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America20130—