510(k) Report

Devices descending from K980653

7 later devices reach Perflex Stainless Steel Stent and Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992816Modification to IntrastentIntratherapeutics, Inc.19990—
+1K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992—
+1K991929IntrastentIntratherapeutics, Inc.19993—
+2K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+2K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—
+2K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc.20020—
+2K993904Intrastent Doublestrut LDIntratherapeutics, Inc.200011