BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    INSYTE SIDEHOLDED DRAINAGE CATHETER

    K Number: K950439 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    25
    Review Days
    40

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    Basic Information

    Device Name
    INSYTE SIDEHOLDED DRAINAGE CATHETER
    K Number
    K950439
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vascular Access, Inc.
    Date Received
    February 2, 1995
    Decision Date
    March 14, 1995
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

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