510(k) Report

Devices descending from K011909

5 later devices reach Ultra-Thin SDS Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021630Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp20024—
+2K133110Express LD Biliary Premounted Stent SystemBoston Scientific Corporation20140—
+2K032360Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Boston Scientific Corp20031—
+2K030645Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp20032—
+2K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Scimed, Inc.20033—