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

    BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J

    K Number: K052578 · Decision Nov 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    34
    Review Days
    66

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    Basic Information

    Device Name
    BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
    K Number
    K052578
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    September 20, 2005
    Decision Date
    November 25, 2005
    Product Code
    DTK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTK Filter, Intravascular, Cardiovascular

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