510(k) Report

Devices descending from K021210

6 later devices reach Arteria Occlusion Balloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+2K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+2K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+3K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I