510(k) Report

Devices descending from K083300

5 later devices reach Gore Flow Reversal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+1K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+1K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+2K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+3K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I