510(k) Report

Devices descending from K993232

14 later devices reach Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152853WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic…Boston Scientific Corp20150—
+1K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation20115—
+1K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp200610—
+1K012822Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…Boston Scientific Scimed, Inc.20011—
+2K121430Evolution Biliary Stent SystemCook Ireland, Ltd.20130—
+2K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation20124—
+2K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp20096—
+2K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation20096—
+2K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp20087—
+2K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.200301
+3K140630Wallflex Biliary RX Stent SystemBoston Scientific201431
+4K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific20241—
+4K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation20231—
+5K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific20240—