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

    FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)

    K Number: K760152 · Decision Jul 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    12
    Review Days
    18

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    Basic Information

    Device Name
    FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)
    K Number
    K760152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Edwards Laboratories
    Date Received
    July 1, 1976
    Decision Date
    July 19, 1976
    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 Edwards Laboratories

    K Number Device Name
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    K792441 CARPENTIER-EDWARDS FLEX. ANNULOPLASTY
    K792034 INTEGRAL DISPOSABLE HOLDER CARPENTIER
    K790047 CARDIAC OUTPUT COMPUTER, MDEL 9520A
    K790022 DISPOSABLE HOLDER FOR BIOPROSTHESIS
    K781535 AC ADAPTER:MODELS 9525,9526,9527
    K771663 PROBE & CATHETER
    K771046 VENA CAVA UMBRELLA FILTER, MODEL 7321
    K760151 APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)
    Search all 12 clearances from Edwards Laboratories →