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

    VENA CAVA FILTER

    K Number: K901454 · Decision May 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    428

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    Basic Information

    Device Name
    VENA CAVA FILTER
    K Number
    K901454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vena-Tech, Inc.
    Date Received
    March 27, 1990
    Decision Date
    May 29, 1991
    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 Vena-Tech, Inc.

    K Number Device Name
    K881604 VENA CAVA FILTER