510(k) Report

Devices descending from K052659

18 later devices reach Spiderx Embolic Protection Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+1K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+1K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+1K063204Spiderfx Embolic Protection DeviceEv3, Inc.20068—
+2K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+2K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+2K180023WirionGardia Medical, Ltd.20182—
+2K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+2K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K200198WirionCardiovascular Systems, Inc.20201—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+4K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I