510(k) Report

Devices descending from K042218

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153086RX ACCUNET Embolic Protection SystemAbbott Vascular20152—
+1K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+1K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+1K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+1K052659Spiderx Embolic Protection DeviceEv3, Inc.200618—
+1K052166Modification to: RX Accunet Embolic Protection SystemGuidant Corporation200513—
+1K052165RX Accunet Embolic Protection SystemGuidant Corporation20051—
+2K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+2K143570WirionGardia Medical20153—
+2K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+2K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+2K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories200801
+2K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+2K063204Spiderfx Embolic Protection DeviceEv3, Inc.20068—
+3K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+3K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+3K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+3K180023WirionGardia Medical, Ltd.20182—
+3K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+3K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+4K200198WirionCardiovascular Systems, Inc.20201—
+4K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+4K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+4K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+5K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+5K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+6K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I