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

    TITANIUM GREENFIELD VENA CAVA FILTER CARRIER

    K Number: K874096 · Decision Nov 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    36
    Review Days
    393

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    Basic Information

    Device Name
    TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
    K Number
    K874096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medi-Tech, Inc.
    Date Received
    October 8, 1987
    Decision Date
    November 4, 1988
    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 Medi-Tech, Inc.

    K Number Device Name
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    K952056 IMMUNOASSAY DRUGS OF ABUSE CONTROLS
    K945289 DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
    K942551 THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
    K943290 BILIRUBIN PLUS/PEDIATRIC CONTROLS
    K922990 HEMODIALYSIS BATH
    K942552 THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
    K904073 COAGULATION REFERENCE PLASMA, ABNORMAL
    K895819 MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
    Search all 36 clearances from Medi-Tech, Inc. →