510(k) Report

Devices descending from K001917

14 later devices reach Parodi Catheter for Angiography (Parca) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070770Gore Balloon SheathW. L. Gore & Associates, Inc.20076—
+1K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K042117Proxis System, Model Eps 101Velocimed, Inc.20055—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+3K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+3K060651Proxis System, Model EPS101St Jude Medical20063—
+3K052523Proxis SystemVelocimed, Inc.20062—
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+4K073563Modification to Proxis SystemSt Jude Medical20080—
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I