510(k) Report

Devices descending from K011018

2 later devices reach Taut Balloon Catheter, Model 50640 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173414Advance Biliary Balloon CatheterCook Incorporated20181—
+2K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation20220—