510(k) Report

Devices descending from K030053

8 later devices reach Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Abbott Laboratories20037—
+2K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc.20082—
+2K040667Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…Abbott Laboratories20041—
+2K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories20041—
+3K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.20260—
+3K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120—
+3K050534Xpert Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories20050—
+3K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…Abbott Laboratories20040—