BEUDAMED
    FDA Registration Active 🇺🇸 United States

    InZone® Detachment System

    Reg #: 3012931345 · FEI: 3012931345 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Stryker Neurovascular
    Registration Number
    3012931345
    FEI Number
    3012931345
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4870 West 2100 South
    City
    Salt Lake City
    State
    UT
    ZIP
    84120
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212455

    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
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD

    Proprietary Names

    InZone® Detachment System

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)