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

    MICRUS MICROCOIL DELIVERY SYSTEM, MDS03

    K Number: K002056 · Decision Jan 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    6
    Review Days
    189

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    Basic Information

    Device Name
    MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
    K Number
    K002056
    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
    July 6, 2000
    Decision Date
    January 11, 2001
    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
    K032872 MICRUS MICROCOIL SYSTEM
    K032624 MICRUS MICROCATHETER
    K031578 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
    K022420 MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01