BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Stryker Neurovascular

    Reg #: 3008881809 · FEI: 3008881809 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    Stryker Neurovascular
    Registration Number
    3008881809
    FEI Number
    3008881809
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Business and Technology Park, Model Farm Road
    City
    Cork Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K151667
    PMA Number
    H020002

    Owner / Operator

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

    US Agent

    Business Name
    STRYKER Neurovascular
    Contact Name
    Breskella Halteh
    Address
    47900 Bayside Pkwy, --
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US
    Email
    [email protected]
    Phone
    650 8143781

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Catheter, Continuous Flush KRA
    Catheter, Percutaneous, Neurovasculature QJP
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG
    Intracranial Neurovascular Stent NJE
    Catheter, Thrombus Retriever NRY
    Intracranial Coil-Assist Stent QCA
    Catheter, Intravascular Occluding, Temporary MJN
    Intracranial Aneurysm Flow Diverter OUT

    Proprietary Names

    AXS Catalyst 6 AXS Catalyst 5 Excelsior® XT-27® Microcatheters Target Tetra Detachable Coils Excelsior XT-27 Microcatheter Excelsior SL-10 Microcatheter Neuroform EZ Stent System AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter) AXS Catalyst Distal Access Catheter Target XXL 360 Excelsior XT-17 Microcatheter Excelsior XT-17 Flex Microcatheter Target Detachable Coils AXS Offset Delivery Assist Catheter Excelsior 1018 Microcatheter Neuroform Atlas Stent System Excelsior 1018 Pre-Shaped Microcatheter Excelsior SL-10 Pre-Shaped Microcatheter TransForm Super Compliant Occlusion Balloon Catheter TransForm Compliant Occlusion Balloon Catheter Target 360 Standard Target Helical Nano Target 360 Soft Target XL Helical Target Helical Ultra Target XL 360 Soft Target 360 Nano Target 360 Ultra Target XL 360 Standard Target 3D Gateway PTA Balloon Catheter Wingspan Stent System Surpass Streamline Flow Diverter Surpass Evolve Flow Diverter Surpass Elite Flow Diverter System AXS Catalyst Distal Access Catheter (AXS Catalyst 7) Target Detachable Coil Target XL 360+ Target XL 3D Target 360+

    Establishment Types

    Manufacture Medical Device