510(k) Report

Devices descending from K001843

26 later devices reach S.M.a.R.T. Nitinol Stent Transhepatic Biliary System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC20034—
+1K030409Smart Nitinol Stent Endoscopic Biliary SystemCordis Corp.20030—
+1K023217Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200221
+1K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2002241
+1K020052Smart Nitinol Stent Transhepatic Biliary SystemCordis Corp.20024—
+2K053404Lifestent Flexstart Biliary Stent SystemEdwards Lifesciences, LLC20052103
+2K042985Lifestent NT35 Biliary Stent SystemEdwards Lifesciences, LLC20043—
+2K042969Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200402
+2K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp.200335
+2K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.200301
+2K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20039—
+2K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2003103
+2K031197Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20030—
+3K130792Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc.20130—
+3K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions20080—
+3K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc.200816
+3K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp.200842
+3K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc.20066—
+3K060487Lifestent Flexstar XL Biliary Stent SystemEdwards Lifesciences, LLC20061—
+4K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120—
+4K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc.201121
+4K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.201041
+4K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc.20100—
+4K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc.20085—
+5K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20121—
+6K130591Supera VeritasIdev Technologies, Inc.20130—