510(k) Report

Devices descending from K023691

48 later devices reach Boston Scientific Filterwire EX Embolic through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060651Proxis System, Model EPS101St Jude Medical20063—
+1K052523Proxis SystemVelocimed, Inc.20062—
+1K042218Accunet Embolic Protection System, RX Accunet Embolic Protection SystemGuidant Corp.200427—
+1K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi200435—
+2K153086RX ACCUNET Embolic Protection SystemAbbott Vascular20152—
+2K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+2K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+2K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+2K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+2K073563Modification to Proxis SystemSt Jude Medical20080—
+2K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+2K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+2K053195Spiderx Embolic Protection DeviceEv3, Inc.200614—
+2K051984Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300Boston Scientific Corp20067—
+2K052659Spiderx Embolic Protection DeviceEv3, Inc.200618—
+2K052280Filterwire EZ Embolic Protection SystemBoston Scientific Corp20051—
+2K052166Modification to: RX Accunet Embolic Protection SystemGuidant Corporation200513—
+2K052165RX Accunet Embolic Protection SystemGuidant Corporation20051—
+2K051179EZ Plus Retrieval Sheath, Model 38899-150Boston Scientific Corp20050—
+3K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+3K143570WirionGardia Medical20153—
+3K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+3K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+3K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories200801
+3K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+3K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+3K063204Spiderfx Embolic Protection DeviceEv3, Inc.20068—
+3K061332Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp20066—
+3K062201Spiderx Embolic Protection DeviceEv3, Inc.200613—
+4K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+4K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+4K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+4K180023WirionGardia Medical, Ltd.20182—
+4K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+4K063785Spiderfx Embolic Protection DeviceEv3, Inc.200712—
+5K200198WirionCardiovascular Systems, Inc.20201—
+5K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+5K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+5K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.201010—
+5K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+6K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+6K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+6K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd.20115—
+7K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+7K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20120—
+7K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+8K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+9K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—