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

    MANAN MALECOT BASKET DRAINAGE CATHETER

    K Number: K981258 · Decision Apr 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    46
    Review Days
    16

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    Basic Information

    Device Name
    MANAN MALECOT BASKET DRAINAGE CATHETER
    K Number
    K981258
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Device Technologies, Inc.
    Date Received
    April 6, 1998
    Decision Date
    April 22, 1998
    Product Code
    FEW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FEW Catheter, Malecot

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