510(k) Report

Devices descending from K964688

38 later devices reach Long Medium Palmaz-Schatz Balloon Expandable Stent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810Jomed AG20038—
+1K993904Intrastent Doublestrut LDIntratherapeutics, Inc.200011
+1K992816Modification to IntrastentIntratherapeutics, Inc.19990—
+1K991929IntrastentIntratherapeutics, Inc.19993—
+1K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.199919—
+1K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Cordis Corp.199921—
+1K980290Iti StentIntratherapeutics, Inc.1998412
+1K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987—
+2K033537Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006…Abbott Laboratories20037—
+2K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc.20020—
+2K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery SystemCordis Corp.20015—
+2K012090Cordis Palmaz Genesis Transhepatic Biliary StentCordis, A Johnson & Johnson Co.20016—
+2K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992—
+2K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Cordis, A Johnson & Johnson Co.199917—
+2K991674Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Models…Cordis Corp.19990—
+3K092352Scuba Biliary Stent SystemInvatec S.P.A.20100—
+3K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc.20082—
+3K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+3K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—
+3K040667Xpert Biliary Stent, Models EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008…Abbott Laboratories20041—
+3K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories20041—
+3K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp.200311
+3K021630Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Corp20024—
+3K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.20020—
+3K012087Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.20010—
+3K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.20019—
+3K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Cordis Corp.200011—
+4K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.20260—
+4K133110Express LD Biliary Premounted Stent SystemBoston Scientific Corporation20140—
+4K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120—
+4K050534Xpert Self-Expanding Transhepatic Biliary Stent SystemAbbott Laboratories20050—
+4K041962Xpand Balloon-Expandable Transhepatic Biliary Stent System, Models 20587, 20588, 20589…Abbott Laboratories20040—
+4K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.20042—
+4K032360Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express…Boston Scientific Corp20031—
+4K030645Boston Scientific Express Biliary LD Unmounted StentBoston Scientific Corp20032—
+4K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemBoston Scientific Scimed, Inc.20033—
+5K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation20061—
+6K063481Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc.20070—