510(k) Report

Devices descending from K052454

14 later devices reach The Emboshield Embolic Protection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081523Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions20084—
+1K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+2K141678Emboshield NAV6 Embolic Protection SystemAbbott Vascular20141—
+2K121015Emboshield NAV6 Embolic Protection SystemAbbott Vascular20122—
+2K110909Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM…Abbott Laboratories20113—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+3K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular20190—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+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