510(k) Report

Devices descending from K042908

20 later devices reach RX Accunet 2 Embolic Protection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052454The Emboshield Embolic Protection SystemAbbott Vascular Devices200514—
+1K052166Modification to: RX Accunet Embolic Protection SystemGuidant Corporation200513—
+2K153086RX ACCUNET Embolic Protection SystemAbbott Vascular20152—
+2K081523Emboshield NAV6 Embolic Protection SystemAbbott Vascular-Vascular Solutions20084—
+2K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories200801
+2K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+3K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+3K141678Emboshield NAV6 Embolic Protection SystemAbbott Vascular20141—
+3K121015Emboshield NAV6 Embolic Protection SystemAbbott Vascular20122—
+3K110909Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wire-Workhorse-190CM…Abbott Laboratories20113—
+3K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+4K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+4K191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresAbbott Vascular20190—
+4K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+4K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+4K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+4K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+5K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+6K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I