510(k) Report

Devices descending from K003992

53 later devices reach Percusurge Guardwire Temporary Occlusion and Aspiration System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031946Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-LargeEdwards Lifesciences, LLC20032—
+1K023691Boston Scientific Filterwire EX EmbolicBoston Scientific Epi200348—
+1K022071Embol-X Aortic Filters,Etra-Small,Small,Medium,Large,Extra Large,Models…Embol-X, Inc.20033Class I
+2K141465Cardiogard Emboli Protection CannulaCardiogard Medical, Ltd.20151—
+2K060651Proxis System, Model EPS101St Jude Medical20063—
+2K052523Proxis SystemVelocimed, Inc.20062—
+2K042218Accunet Embolic Protection System, RX Accunet Embolic Protection SystemGuidant Corp.200427—
+2K032884Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval SheathBoston Scientific Epi200435—
+3K182302CardioGard Emboli Protection CannulaCardiogard Medical, Ltd.20190—
+3K153086RX ACCUNET Embolic Protection SystemAbbott Vascular20152—
+3K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+3K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+3K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+3K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+3K073563Modification to Proxis SystemSt Jude Medical20080—
+3K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+3K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+3K053195Spiderx Embolic Protection DeviceEv3, Inc.200614—
+3K051984Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300Boston Scientific Corp20067—
+3K052659Spiderx Embolic Protection DeviceEv3, Inc.200618—
+3K052280Filterwire EZ Embolic Protection SystemBoston Scientific Corp20051—
+3K052166Modification to: RX Accunet Embolic Protection SystemGuidant Corporation200513—
+3K052165RX Accunet Embolic Protection SystemGuidant Corporation20051—
+3K051179EZ Plus Retrieval Sheath, Model 38899-150Boston Scientific Corp20050—
+4K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+4K143570WirionGardia Medical20153—
+4K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+4K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+4K081549RX Accunet LP Embolic Protection SystemAbbott Laboratories200801
+4K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+4K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+4K063204Spiderfx Embolic Protection DeviceEv3, Inc.20068—
+4K061332Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp20066—
+4K062201Spiderx Embolic Protection DeviceEv3, Inc.200613—
+5K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+5K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+5K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+5K180023WirionGardia Medical, Ltd.20182—
+5K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+5K063785Spiderfx Embolic Protection DeviceEv3, Inc.200712—
+6K200198WirionCardiovascular Systems, Inc.20201—
+6K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+6K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+6K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.201010—
+6K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+7K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+7K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+7K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd.20115—
+8K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+8K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20120—
+8K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+9K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+10K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—