510(k) Report

Devices descending from K033736

159 later devices reach Merci Retriever, Models 90065, 90066 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072718Penumbra SystemPenumbra, Inc.20071201
+1K063774Modification to Merci Retriever, Models X5 and X6Concentric Medical, Inc.200737—
+2K142458Penumbra System ACEPenumbra, Inc.201560—
+2K133317Penumbra System / Penumbra System MaxPenumbra, Inc.201461—
+2K122772Penumbra DDC CathetersPenumbra, Inc.20124—
+2K121917Penumbra Embolectomy Aspiration SystemPenumbra, Inc.201243—
+2K120961Trevo RetrieverConcentric Medical, Inc.2012171
+2K113455Solitaire FR Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular201222—
+2K113163Penumbra System MaxPenumbra, Inc.2011116—
+2K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc.2010118—
+2K093970Pica CatheterPenumbra, Inc.20105—
+2K090085Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113Concentric Medical, Inc.200923—
+3K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited20260—
+3K240917Esperance 3+ Aspiration Catheter SystemWallaby Medical20240—
+3K223913Socrates Aspiration SystemScientia Vascular, Inc.202301
+3K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20231—
+3K211697Esperance Aspiration Catheter SystemWallaby Medical20211—
+3K190338046 Zenith FlexInneuroco, Inc.20193—
+3K190779Trevo XP ProVue RetrieverStryker20195Class I
+3K173452EmboTrap ll Revascularization DeviceNeuravi, Ltd.20184—
+3K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.201654—
+3K153071Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201510—
+3K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc.20153—
+3K151623Penumbra System 110 Aspiration TubingPenumbra, Inc.20152—
+3K142870Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.201542—
+3K141516Mindframe Capture LP Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20150Class I
+3K141491Solitaire 2 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201417—
+3K123378Solitaire 2 Revascularization DeviceMicro Therapeutics Dba Ev3 Neurovascular201218—
+3K122478Modified Trevo RetrieverConcentric Medical, Inc.201210—
+4K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc.20260—
+4K251357Esperance pHLO Aspiration SystemPhenox, Ltd.20260—
+4K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.20250—
+4K250787Liberant Thrombectomy SystemMedtronic, Ireland20250—
+4K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…Cerenovus, Inc.20241—
+4K230030Excipio SV Aspiration Catheter and TubingContego Medical, Inc.20230—
+4K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC20230—
+4K223216Symphony Thrombectomy SystemTruvic Medical, Inc.20233—
+4K214114Prodigy Thrombectomy SystemTruvic Medical, Inc.20220—
+4K212908EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20211—
+4K211338EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20212—
+4K203592Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical, Ltd.20215—
+4K203219Trevo XP ProVue Retriever and Trevo NXT™ ProVue RetrieverStryker Neurovascular20202—
+4K193595Indigo Aspiration System - Aspiration Catheter 7 and Separator 7Penumbra, Inc.20201—
+4K193063EMBOTRAP III Revascularization DeviceNeuravi, Ltd.20203—
+4K192981Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12Penumbra, Inc.202012—
+4K192833Indigo Aspiration SystemPenumbra, Inc.20195—
+4K192207Trevo NXT ProVue RetrieverStryker20194—
+4K181186Solitare Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20183—
+4K182522Penumbra System (Modified 110 Aspiration Tubing)Penumbra, Inc.20181—
+4K181060Solitaire 2 and Solitaire Platinum Revascularization DeviceMedtronic Neurovascular20180—
+4K173200SOFIA Plus Aspiration CatheterMicroVention, Inc.20185—
+4K171672065 Zenith, 074 ZenithInneuroco, Inc.20171—
+4K160641Solitaire Platinum Revascularization Device, 6x40 mmMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20178—
+4K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20165—
+4K161262Super Distal Access (SDA)Inneuroco, Inc.20160—
+4K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201615—
+4K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.201631—
+4K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.201627—
+4K133464Modified Trevo Provue RetrieverConcentric Medical, Inc.201401
+4K132641Modified Trevo Provue RetrieverConcentric Medical, Inc.201434
+5K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—
+5K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.202601
+5K253062Tigertriever 25 Revascularization DeviceRapid Medical, Ltd.20260—
+5K251070Akura Thrombectomy SystemAkura Medical20250—
+5K251603Tigertriever 17 Ultra Revascularization DeviceRapid Medical, Ltd.20250—
+5K251789EMBOTRAP III Revascularization DeviceNeuravi Limited20250—
+5K250775Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20252—
+5K242319Indigo® Aspiration System – Aspiration Catheter 6XPenumbra, Inc.20240—
+5K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.20234—
+5K230429Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device…Rapid Medical, Ltd.20230—
+5K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.20230Class I
+5K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc.20228—
+5K220808Tigertriever 13 Revascularization DeviceRapid Medical, Ltd.20222—
+5K220270Aspirex Thrombectomy SystemC.R. Bard, Inc.20221—
+5K211120ERIC Retrieval DeviceMicroVention, Inc.202201
+5K210502Trevo NXT ProVue RetrieverStryker Neurovascular20211—
+5K210083Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7Penumbra, Inc.20210—
+5K193576Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—
+5K202821Indigo Aspiration System - Aspiration Catheter 12 and Separator 12Penumbra, Inc.20200—
+5K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+5K200771Indigo Aspiration System Lightning Aspiration TubingPenumbra, Inc.20200—
+5K200117Trevo NXT ProVue RetrieverStryker20203—
+5K183022Solitaire 4 Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20192—
+5K182101Riptide Aspiration System (React 71 Catheter)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20180—
+5K180705Riptide Aspiration System React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20181—
+5K172167Zenith Flex SystemInneuroco, Inc.201871
+5K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker20186—
+5K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc.20180—
+5K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20173—
+5K162901Penumbra 3D Revascularization DevicePenumbra, Inc.201716Class I
+5K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.201617—
+5K161523INDIGO Aspiration SystemPenumbra, Inc.201626—
+5K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc.20151—
+5K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc.201513
+6K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.20260—
+6K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.20260—
+6K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+6K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc.20251—
+6K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…Perfuze, Ltd.20243—
+6K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterPenumbra, Inc.20240—