510(k) Report

Devices descending from K952968

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121614Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp201283
+2K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated20181—
+2K132383Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation CatheterGyrus Acmi, Inc.201401
+2K130804Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation201341
+3K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.20250—
+3K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.20200—
+3K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.20190—
+3K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated20180—
+3K132181Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation CatheterOlympus Surgical Technologies America20130—