510(k) Report

Devices descending from K972825

20 later devices reach OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993639RX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation…Guidant Corp.20000—
+1K983055RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20…Guidant Corp.199811—
+1K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987—
+2K033875Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc.20041—
+2K012050Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp.20017—
+2K992816Modification to IntrastentIntratherapeutics, Inc.19990—
+2K992319RX Megalink SDS Biliary Stent System, Otw Megalink SDS Biliary Stent SystemGuidant Corp.19992—
+2K991929IntrastentIntratherapeutics, Inc.19993—
+3K113300Atb Advance Pta Dilatation CatheterCook, Inc.20110—
+3K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+3K060817Omnilink. 018 Biliary Stent SystemGuidant Endovascular Solutions, Inc.20060—
+3K053459Omnilink .035 Biliary Stent SystemGuidant Corporation20060—
+3K020528Intrastent LD (Large Diameter) StentSulzer Intratherapeutics, Inc.20020—
+3K993904Intrastent Doublestrut LDIntratherapeutics, Inc.200011
+4K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+4K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+5K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+5K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+5K151317Armada 18 PTA CatheterAbbott Vascular20150—
+5K121352Armada 14XXT Pta CatheterAbbott Vascular20120—