510(k) Report

Devices descending from K052166

13 later devices reach Modification to: RX Accunet Embolic Protection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153086RX ACCUNET Embolic Protection SystemAbbott Vascular20152—
+1K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories200801
+1K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+2K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+3K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+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