510(k) Report

Devices descending from K960806

186 later devices reach Turbo Tracker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+1K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+1K032624Micrus MicrocatheterMicrus Corp.200319—
+1K030637Ekos Peripheral Infusion SystemEkos Corp.200350—
+1K020733PVS 1500 SDSPrecision Vascular Systems, Inc.200221—
+1K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000120—
+1K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target20006—
+1K974222Ces Masstransit Infusion CatheterCordis Neurovascular, Inc.19980—
+2K123452Tracker-17 Microcather, 150 CM Long and 15.0 CM Flexible Distal Shaft, Tracker-17…Stryker20131—
+2K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084—
+2K073166Endowave Infusion SystemEkos Corp.200811—
+2K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+2K060116Micrus Courier MicrocathetersMicrus Endovascular Corporation200618—
+2K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+2K050599Tracker Excel -14 Pre-Shaped MicrocatheterBoston Scientific Corp200535—
+2K050630Pivot Steerable MicrocatheterBoston Scientific - Precision Vascular200501
+2K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp2004257
+2K033726PVS Pivot Steerable Delivery System MicrocatheterPrecision Vascular20041—
+2K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+2K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+2K032494PVS 1700 Steerable Delivery System MicrocatheterPrecision Vascular Systems, Inc.200320—
+2K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target2001812
+3K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3Asahi Intecc Co., Ltd.20240—
+3K210601Plato 17 MicrocatheterScientia Vascular, LLC202111
+3K173548Merit Pursue MicrocatheterMerit Medical Systems, Inc.201801
+3K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17…Stryker Neurovascular20140—
+3K113819Mongoose Angiographic CatheterPediacath, Inc.20121—
+3K113778Excelsior XT-27 MicrocatheterStryker Neurovascular201283
+3K112828Revive Intermediate Catheter (Revive IC)Codman & Shurtleff, Inc.20110—
+3K101542Headway 17 Advanced MicrocatheterMicroVention, Inc.201031
+3K100826Penumbra Catherer 025Penumbra, Inc.20102—
+3K092702Micrus Microcatheter, Model Courier 270Micrus Endovascular Corporation20090—
+3K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation20093—
+3K083922Micrus Microcatheter, Courier Flex, Model MSF 170000-00Micrus Endovascular Corporation20090—
+3K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd.200933—
+3K083343Headway 17 MicrocatheterMicroVention, Inc.200839—
+3K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+3K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+3K062885Stride MicrocatheterAsahi Intecc Co., Ltd.200734—
+3K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation20067—
+3K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+3K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+3K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+3K041629Lysus Infusion SystemEkos Corp.200439—
+4K254071p17 XR MicrocatheterWallaby Medical20260—
+4K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…Stryker Neurovascular20250—
+4K223560Plato 17 MicrocatheterScientia Vascular, Inc.202301
+4K172014Wedge MicrocatheterMicroVention, Inc.20183—
+4K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+4K171264Royal Flush CatheterCook Incorporated20180—
+4K171176M-CATH MicrocatheterAcrostak (Schweiz) AG20170—
+4K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+4K161126ASAHI Corsair ProAsahi Intecc Co., Ltd.201611—
+4K152840Lantern Delivery MicrocatheterPenumbra, Inc.20151—
+4K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd.201520—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.201331
+4K130858Reverse Medical MicrocatheterReverse Medical Corporation20131—
+4K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20134—
+4K122684Reverse Medical MicrocatheterReverse Medical Corporation20122—
+4K121785Scepter C Occlusion Balloon CatheterMicroVention, Inc.20122—
+4K120917Headway Duo MicrocatheterMicroVention, Inc.201212—
+4K112035Valet Micro CatheterVolcano Corporation20129—
+4K111705Ekosonic Endovascular SystemEkos Corporation201195
+4K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation20112—
+4K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc.200919—
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation20076—
+4K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+4K062507Micro-Infusion SystemEkos Corp.200613—
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+4K050472Lysus Infusion SystemEkos Corp.20050—
+4K042456Lysus Infusion SystemEkos Corp.2004383
+5K242033Access25™ Delivery MicrocatheterPenumbra, Inc.20240—
+5K232542Wedge XL Delivery CatheterMicroVention, Inc.20240—
+5K230609NG Delivery CatheterBalt USA, LLC20231—
+5K203842Bendit21 MicrocatheterBend IT Technologies, Ltd.20221—
+5K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+5K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+5K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+5K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+5K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+5K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+5K182487CerusEndo MicrocatheterCerus Endovascular, Inc.20190—
+5K182829Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.20190—
+5K183045Eclipse 2LBalt USA, LLC20190—
+5K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+5K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+5K182360Teleport MicrocatheterOrbusneich Medical Trading, Inc.20182—
+5K170664Odyssey Micro CatheterHeraeus Medical Components, LLC20170—
+5K171268Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20170—
+5K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc.20164—
+5K152249ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20163—
+5K152447ASAHI CaravelAsahi Intecc Co., Ltd.20162—
+5K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+5K142692Occlusion Balloon CatheterEmbolx, Inc.20151—
+5K143744MicroCross CatheterRoxwood Medical, Inc.20151—
+5K141649Spex Support CatheterReflow Medical20146—
+5K131482Sofia Distal Access CatheterMicroVention, Inc.201311—