510(k) Report

Devices descending from K032884

35 later devices reach Filter Wire EZ Embolic Protection System and EZ Bent Tip Retrieval Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+1K063313Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM)Boston Scientific Corp200646
+1K053195Spiderx Embolic Protection DeviceEv3, Inc.200614—
+1K051984Filterwire EZ (2.25 MM - 3.5 MM) Embolic Protection System, Models 20120-190, 20120-300Boston Scientific Corp20067—
+1K052659Spiderx Embolic Protection DeviceEv3, Inc.200618—
+1K052280Filterwire EZ Embolic Protection SystemBoston Scientific Corp20051—
+1K051179EZ Plus Retrieval Sheath, Model 38899-150Boston Scientific Corp20050—
+2K143570WirionGardia Medical20153—
+2K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+2K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+2K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+2K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+2K063204Spiderfx Embolic Protection DeviceEv3, Inc.20068—
+2K061332Filterwire EZ Embolic Protection System (2.25 MM-3.5 MM)Boston Scientific Corp20066—
+2K062201Spiderx Embolic Protection DeviceEv3, Inc.200613—
+3K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+3K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+3K180023WirionGardia Medical, Ltd.20182—
+3K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+3K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K063785Spiderfx Embolic Protection DeviceEv3, Inc.200712—
+4K200198WirionCardiovascular Systems, Inc.20201—
+4K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+4K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+4K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+4K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.201010—
+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
+5K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd.20115—
+6K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+6K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20120—
+6K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+7K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+8K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—