510(k) Report

Devices descending from K970041

4 later devices reach Ascend Balloon Dailation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172588Balloon Catheter and Balloon Ureteral Dilator SetCook Incorporated20180—
+1K072749Sialo Balloon Dilatation CatheterSialo Technology, Ltd.20081—
+1K040127Cook Ureteral Balloon Dilation Catheter SetCook Urological, Inc.20040—
+2K140593Advance Salivary Balloon Catheter with Wire GuideCook, Inc.20140—