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

    NAVARRE PERCUTANEOUS ACCESS SET

    K Number: K942315 · Decision Jul 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    214
    Registration Numbers
    214
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    56

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    Basic Information

    Device Name
    NAVARRE PERCUTANEOUS ACCESS SET
    K Number
    K942315
    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
    Navarre Biomedical , Ltd.
    Date Received
    May 13, 1994
    Decision Date
    July 8, 1994
    Product Code
    KGZ
    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
    KGZ Accessories, Catheter

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    Other Clearances by Navarre Biomedical , Ltd.

    K Number Device Name
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    K943663 NAVARRE 600 ML DRAINAGE BAG
    K933600 NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
    K932391 NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET