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

    PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES

    K Number: K073419 · Decision Feb 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES
    K Number
    K073419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rj Medical, Inc.
    Date Received
    December 5, 2007
    Decision Date
    February 14, 2008
    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 Rj Medical, Inc.

    K Number Device Name
    K073544 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA FOAM EMBOLIZATION PARTICLES