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

    MCPARLAND SCALP VEIN CATHETER

    K Number: K821001 · Decision Jul 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    35
    Review Days
    105

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    Basic Information

    Device Name
    MCPARLAND SCALP VEIN CATHETER
    K Number
    K821001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Renal Systems, Inc.
    Date Received
    April 8, 1982
    Decision Date
    July 22, 1982
    Product Code
    LFJ
    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
    LFJ Catheter, Subclavian

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