510(k) Report

Devices descending from K011656

21 later devices reach Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101570Hyperglide and Hyperform Occlusion Balloon SystemsMicro Therapeutics Dba Ev3 Neurovascular20101—
+1K100063Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide…Ev3, Inc.20102—
+1K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112…Ev3 Neurovascular20098—
+1K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084—
+1K021210Arteria Occlusion BalloonArteria Medical Science, Inc.20026—
+2K122576Transform Occlusion Balloon Catheter (Compliant and Super CompliantStryker Neurovascular201308
+2K110741Scepter C Occlusion Balloon CatheterMicroVention, Inc.20114—
+2K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation20093—
+2K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc.20095—
+3K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+3K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20152—
+3K123156Gore Flow Reversal System Model GFRS073W. L. Gore & Associates, Inc.20120—
+3K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+3K113698Scepter XC Occlusion Balloon CatheterMicroVention, Inc.20123—
+3K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation20112—
+3K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A.200903
+4K183045Eclipse 2LBalt USA, LLC20190—
+4K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+4K142692Occlusion Balloon CatheterEmbolx, Inc.20151—
+5K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I
+5K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.20180—