510(k) Report

Devices descending from K130484

2 later devices reach Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation20171—
+2K241888Single-use Balloon Dilatation CatheterLeo Medical Co., Ltd.20240—