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

    NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER

    K Number: K945909 · Decision Jun 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    9
    Review Days
    182

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    Basic Information

    Device Name
    NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER
    K Number
    K945909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navarre Biomedical , Ltd.
    Date Received
    December 2, 1994
    Decision Date
    June 2, 1995
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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    Other Clearances by Navarre Biomedical , Ltd.

    K Number Device Name
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    K943663 NAVARRE 600 ML DRAINAGE BAG
    K942315 NAVARRE PERCUTANEOUS ACCESS SET
    K933600 NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
    K932391 NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET