510(k) Report

Devices descending from K003410

165 later devices reach Concentric Retriever, Model 90030 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040745Modified Concentric Retriever, Model 90038Concentric Medical, Inc.20041—
+1K040700Concentric Retriever X5, Model 90035; Concentric Retriever X6, Model 90037Concentric Medical, Inc.20040—
+1K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20031642
+2K093610Modified Retriever (Modified, Line Extension), Models 90152, 90153Concentric Medical, Inc.20110—
+2K051838Modified Concentric Retriever, Model 90039Concentric Medical, Inc.20050—
+2K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004159—
+3K072718Penumbra SystemPenumbra, Inc.20071201
+3K063774Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc.200737—
+4K142458Penumbra System ACEPenumbra, Inc.201560—
+4K133317Penumbra System / Penumbra System MaxPenumbra, Inc.201461—
+4K122772Penumbra DDC CathetersPenumbra, Inc.20124—
+4K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc.201243—
+4K120961Trevo RetrieverConcentric Medical, Inc.2012171
+4K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular201222—
+4K113163Penumbra System MaxPenumbra, Inc.2011116—
+4K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc.2010118—
+4K093970Pica CatheterPenumbra, Inc.20105—
+4K090085Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Concentric Medical, Inc.200923—
+5K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+5K240917Esperance 3+ Aspiration Catheter SystemWallaby Medical20240—
+5K223913Socrates Aspiration SystemScientia Vascular, Inc.202301
+5K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20231—
+5K211697Esperance Aspiration Catheter SystemWallaby Medical20211—
+5K190338046 Zenith FlexInneuroco, Inc.20193—
+5K190779Trevo XP ProVue RetrieverStryker20195Class I
+5K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd.20184—
+5K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.201654—
+5K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201510—
+5K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+5K151623Penumbra System 110 Aspiration TubingPenumbra, Inc.20152—
+5K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.201542—
+5K141516Mindframe Capture LP Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20150Class I
+5K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201417—
+5K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular201218—
+5K122478Modified Trevo RetrieverConcentric Medical, Inc.201210—
+6K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.20260—
+6K251357Esperance pHLO Aspiration SystemPhenox, Ltd.20260—
+6K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.20250—
+6K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+6K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…Cerenovus, Inc.20241—
+6K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc.20230—
+6K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20230—
+6K223216Symphony Thrombectomy SystemTruvic Medical, Inc.20233—
+6K214114Prodigy Thrombectomy SystemTruvic Medical, Inc.20220—
+6K212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20211—
+6K211338EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20212—
+6K203592Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical, Ltd.20215—
+6K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular20202—
+6K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201—
+6K193063EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20203—
+6K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.202012—
+6K192833Indigo Aspiration SystemPenumbra, Inc.20195—
+6K192207Trevo NXT ProVue RetrieverStryker20194—
+6K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20183—
+6K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+6K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular20180—
+6K173200SOFIA Plus Aspiration CatheterMicroVention, Inc.20185—
+6K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+6K160641Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20178—
+6K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20165—
+6K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+6K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201615—
+6K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.201631—
+6K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.201627—
+6K133464Modified Trevo Provue RetrieverConcentric Medical, Inc.201401
+6K132641Modified Trevo Provue RetrieverConcentric Medical, Inc.201434
+7K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+7K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+7K253062Tigertriever 25 Revascularization DeviceRapid Medical, Ltd.20260—
+7K251070Akura Thrombectomy SystemAkura Medical20250—
+7K251603Tigertriever 17 Ultra Revascularization DeviceRapid Medical, Ltd.20250—
+7K251789EMBOTRAP III Revascularization DeviceNeuravi Limited20250—
+7K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20252—
+7K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc.20240—
+7K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20234—
+7K230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device…Rapid Medical, Ltd.20230—
+7K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20230Class I
+7K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+7K220808Tigertriever 13 Revascularization DeviceRapid Medical, Ltd.20222—
+7K220270Aspirex Thrombectomy SystemC.R. Bard, Inc.20221—
+7K211120ERIC Retrieval DeviceMicroVention, Inc.202201
+7K210502Trevo NXT ProVue RetrieverStryker Neurovascular20211—
+7K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc.20210—
+7K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—
+7K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+7K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+7K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+7K200117Trevo NXT ProVue RetrieverStryker20203—
+7K183022Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20192—
+7K182101Riptide Aspiration System (React 71 Catheter)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+7K180705Riptide Aspiration System React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20181—
+7K172167Zenith Flex SystemInneuroco, Inc.201871
+7K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker20186—
+7K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+7K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20173—
+7K162901Penumbra 3D Revascularization DevicePenumbra, Inc.201716Class I
+7K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201617—
+7K161523INDIGO Aspiration SystemPenumbra, Inc.201626—
+7K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc.20151—
+7K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc.201513