510(k) Report

Devices descending from K023878

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073523Interceptor Plus Coronary Filter SystemsMedtronic, Inc.20080—
+1K072990Guardwire Temporary Occlusion and Aspiration System- CarotidMedtronic, Inc.20078—
+1K060651Proxis System, Model EPS101St Jude Medical20063—
+1K053195Spiderx Embolic Protection DeviceEv3, Inc.200614—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K082348Fibernet Embolic Protection SystemLumen Biomedical, Inc.200812
+2K073563Modification to Proxis SystemSt Jude Medical20080—
+2K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+2K062201Spiderx Embolic Protection DeviceEv3, Inc.200613—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K111987Fibernet Embolic Protection DeviceLumen Biomedical, Inc.20110—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+3K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+3K063785Spiderfx Embolic Protection DeviceEv3, Inc.200712—
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K090364Extra Pta Balloon Catheter with Embolic Protection FeatureAngioslide, Ltd.201010—
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+5K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+5K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd.20115—
+6K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+6K180023WirionGardia Medical, Ltd.20182—
+6K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20120—
+6K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+7K200198WirionCardiovascular Systems, Inc.20201—
+7K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+8K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+8K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—