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

    MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES

    K Number: K053548 · Decision Jan 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
    K Number
    K053548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Protein Polymer Technologies, Inc.
    Date Received
    December 20, 2005
    Decision Date
    January 30, 2006
    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 Protein Polymer Technologies, Inc.

    K Number Device Name
    K061790 PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES