510(k) Report

Devices descending from K990487

27 later devices reach Equinox Occlusion Balloon System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+1K031357Guarddog Occlusion System, Occlusion Guidewire, 300 CM, Guarddog Occlusion System…Possis Medical, Inc.20042—
+1K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036—
+1K023914Coaxia Flocontrol CatheterCoaxia, Inc.20036—
+1K021210Arteria Occlusion BalloonArteria Medical Science, Inc.20026—
+1K994141Catheter, Intravascular Occluding, Temporary, Model Sol 3510; Wire, Guide, Catheter…Medtronic Ave, Inc.20000—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308
+2K090970Flocontrol , Model 1028Coaxia, Inc.20091—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+2K080700Duoflo CatheterThermopeutix, Inc.20083—
+2K062220Modification to Guarddog Occlusion SystemPossis Medical, Inc.20061—
+2K042117Proxis System, Model Eps 101Velocimed, Inc.20055—
+3K192786Gatekeeper Balloon CatheterArch Catheter, LLC20200—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K112219Tapas CatheterThermopeutix, Inc.20111—
+3K093847Duflo Catheter (Heparin Coated)Thermopeutix, Inc.20100—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+3K081454Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc.20080—
+3K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+3K060651Proxis System, Model EPS101St Jude Medical20063—
+3K052523Proxis SystemVelocimed, Inc.20062—
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K141175Renovocath RC120Renovorx, Inc.201401
+4K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+4K073563Modification to Proxis SystemSt Jude Medical20080—
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I