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

    PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST

    K Number: K932921 · Decision Aug 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST
    K Number
    K932921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun Vena-Tech
    Date Received
    June 15, 1993
    Decision Date
    August 30, 1993
    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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    Other Clearances by B. Braun Vena-Tech

    K Number Device Name
    K925679 VENA CAVA FILTER SYSTEMS, MODIFICATION