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

    MICRUS MICROCATHETER

    K Number: K032624 · Decision Sep 10, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    MICRUS MICROCATHETER
    K Number
    K032624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micrus Corp.
    Date Received
    August 26, 2003
    Decision Date
    September 10, 2003
    Product Code
    DQO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Micrus Corp.

    K Number Device Name
    K033813 MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
    K032872 MICRUS MICROCOIL SYSTEM
    K031578 MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
    K022420 MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
    K002056 MICRUS MICROCOIL DELIVERY SYSTEM, MDS03