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

    TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B

    K Number: K003964 · Decision Jan 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    315
    Review Days
    28

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    Basic Information

    Device Name
    TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
    K Number
    K003964
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis Corp.
    Date Received
    December 22, 2000
    Decision Date
    January 19, 2001
    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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