BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Synxess Neurovascular Guidewire

    K Number: K240871 · Decision Nov 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    234

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    Basic Information

    Device Name
    Synxess Neurovascular Guidewire
    K Number
    K240871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Enlight Medical Technologies (Shenzhen) Co., Ltd.
    Date Received
    March 29, 2024
    Decision Date
    November 18, 2024
    Product Code
    MOF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOF Guide, Wire, Catheter, Neurovasculature

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