510(k) Report

Devices descending from K010838

17 later devices reach Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033217Pheron Pta CatheterBiotronik, Inc.20038—
+1K020854Modification to Fox Pta CatheterJomed AG200216—
+2K082933Passeo-35 Pta CatheterBiotronik, Inc.20085—
+2K072765Passeo 18Biotronik, Inc.20077—
+2K060927Ceres Pta Catheter Models PTA018,PTA035 Various SizesCeres Medical Systems, LLC20060—
+2K040954Fox Plus Pta CatheterAbbott Laboratories, Inc.20045—
+3K151744Passeo-18 Peripheral Dilation CatheterBiotronik, Inc.20151—
+3K142379Passeo-35 PTA CatheterBiotronik, Inc.20143—
+3K130161Passeo-35Biotronik, Inc.20130—
+3K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions20081—
+3K051519Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series)Abbott Laboratories (Perclose, Inc.)20052—
+4K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+4K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc.20231—
+4K152240Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc.20151—
+4K080925Fox Plus Pta CatheterAbbott Vascular, Inc.20080—
+4K062843Fox SV Pta CatheterAbbott Laboratories20061—
+5K072824Fox SV Pta CatheterAbbott Laboratories20070—