BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stryker Neurovascular

    Reg #: 3008853977 · FEI: 3008853977 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    81
    Establishment Types
    3
    Classifications
    17

    Registration Details

    Registration Name
    Stryker Neurovascular
    Registration Number
    3008853977
    FEI Number
    3008853977
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    47900 Bayside Parkway
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143077
    PMA Number
    H050001

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Catheter, Thrombus Retriever NRY
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    Catheter, Percutaneous DQY
    Intracranial Neurovascular Stent NJE
    Catheter, Continuous Flush KRA
    Catheter, Percutaneous, Neurovasculature QJP
    Wire, Guide, Catheter DQX
    Guide, Wire, Catheter, Neurovasculature MOF
    Catheter, Intravascular, Diagnostic DQO
    Intracranial Aneurysm Flow Diverter OUT
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Dilator, Catheter GCC
    Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment POL
    Catheter, Intravascular Occluding, Temporary MJN
    Intracranial Coil-Assist Stent QCA
    Introducer, Catheter DYB

    Proprietary Names

    Trevo XP ProVue Retriever, 6x25mm InZone Detachment System Excelsior XT-17 Microcatheter Excelsior XT-17 Flex Microcatheter Gateway PTA Balloon Catheter Wingspan Stent System Excelsior 1018 Microcatheter Broadway 8 Catheter Synchro2 Support Guidewire Renegade-18 Fiber Braided Microcatheter Trevo Trak 21 Microcatheter Trevo XP ProVue Retriever, 4x30mm AXS Vecta 71 Intermediate Catheter AXS Vecta 74 Intermediate Catheter Surpass Streamline Flow Diverter Surpass Evolve Flow Diverter Surpass Elite Flow Diverter System AXS Lift Intracranial Base Catheter Excelsior SL-10 Microcatheter AXS Infinity Plus Echo Intracranial Base Catheter Excelsior XT-27 Microcatheter Trevo NXT ProVue Retriever Transend EX Guidewire with ICE Hydrophilic Coating TransForm Super Compliant Occlusion Balloon Catheter TransForm Compliant Occlusion Balloon Catheter Transend 300 Floppy Guidewire with ICE Hydrophilic Coating Transend 300 ES Guidewire with ICE Hydrophilic Coating Guidewire with ICE Hydrophilic Coating Guider Softip XF Guide Catheter AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter) InZone® Detachment System Target Detachable Coils AXS Vecta 74 Aspiration Catheter AXS Vecta 71 Aspiration Catheter AXS Catalyst 6 AXS Catalyst 5 Synchro-14 Guidewire Neuroform EZ Stent System FlowGate2 Balloon Guide Catheter, 8F AXS Vecta 46 Intermediate Catheter AXS Catalyst Distal Access Catheter Synchro SELECT Guidewire DAC 038 (125cm, 136cm); DAC 044 (115cm, 130cm, 136cm); DAC 057 (115cm, 125cm); DAC 070 (105cm, 120cm); Target Tetra Detachable Coils Trevo XP ProVue Retriever Excelsior XT-21 Microcatheter Synchro2 Guidewire 010 Guidewire with ICE Hydrophilic Coating Neuro Renegade Hi-Flo Microcatheter Trevo Pro 18 Microcatheter AXS Offset Delivery Assist Catheter Merci 8F Balloon Guide Catheter Merci 9F Balloon Guide Catheter Neuroform Atlas Stent System Target 360 Ultra Target 360 Soft Target XL 360 Soft Target Helical Ultra Target Detachable Coil Target XL 360+ Target XL Helical Target XL 360 Standard Target 3D Target XL 3D Target 360+ AXS Catalyst Distal Access Catheter (AXS Catalyst 7) Target XXL 360 Excelsior 1018 Pre-Shaped Microcatheter Excelsior SL-10 Pre-Shaped Microcatheter AXS Vecta 74 Aspiration System Target 360 Standard Target Helical Nano Target 360 Nano Synchro-10 Guidewire AXS Vecta 71 Aspiration System AXS Infinity LS Plus Long Sheath Trevo XP ProVue Retriever, 3x20mm Trevo XP ProVue Retriever, 4x20mm InZone IST Detachment System; IZDS Connecting Cable IZDS Connecting Cable Excelsior® XT-27® Microcatheters

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device