510(k) Report

Devices descending from K003085

7 later devices reach Concentric Guide Catheter, Models 90018, 90020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070770Gore Balloon SheathW. L. Gore & Associates, Inc.20076—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+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
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I