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

    MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR

    K Number: K031578 · Decision Aug 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    6
    Review Days
    73

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR
    K Number
    K031578
    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
    May 20, 2003
    Decision Date
    August 1, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HCG), ordered by most recent decision date.

    Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Optima Coil System (OptiOne Coil System)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Target Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Neurology

    InZone IST Detachment System; IZDS Connecting Cable

    FDA 510(k)
    FDA Class 2 ·Neurology

    Optima Coil System (Optima Packing Coil System)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Numen™ Coil Embolization System; NumenFR™ Detachment System

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Micrus Corp.

    K Number Device Name
    K033813 MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
    K032872 MICRUS MICROCOIL SYSTEM
    K032624 MICRUS MICROCATHETER
    K022420 MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01
    K002056 MICRUS MICROCOIL DELIVERY SYSTEM, MDS03