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

    MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F

    K Number: K050558 · Decision Aug 29, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    645
    Review Days
    179

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    Basic Information

    Device Name
    MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
    K Number
    K050558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    March 3, 2005
    Decision Date
    August 29, 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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