BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MICRUS MICROCOIL SYSTEM

    K Number: K032872 · Decision Nov 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    6
    Review Days
    74

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    Basic Information

    Device Name
    MICRUS MICROCOIL SYSTEM
    K Number
    K032872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micrus Corp.
    Date Received
    September 15, 2003
    Decision Date
    November 28, 2003
    Product Code
    HCG
    Advisory Committee
    Neurology
    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
    HCG Device, Neurovascular Embolization

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    Other Clearances by Micrus Corp.

    K Number Device Name
    K033813 MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
    K032624 MICRUS MICROCATHETER
    K031578 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
    K022420 MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
    K002056 MICRUS MICROCOIL DELIVERY SYSTEM, MDS03