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

    EUROMEDICAL HAEMATURIA FOLEY CATHETER

    K Number: K973076 · Decision Sep 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    9
    Review Days
    394

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    Basic Information

    Device Name
    EUROMEDICAL HAEMATURIA FOLEY CATHETER
    K Number
    K973076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unomedical Sdn Bhd
    Date Received
    August 18, 1997
    Decision Date
    September 16, 1998
    Product Code
    EZL
    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
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by Unomedical Sdn Bhd

    K Number Device Name
    K962389 EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
    K954751 SILICONE ENDOTRACHEAL TUBE
    K954753 PEDIATRIC SILICONE ENDOTRACHEAL TUBE
    K954750 PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K954754 WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K951696 ENDOTRACHEAL TUBE
    K951697 PEDIATRIC ENDOTRACHEAL TUBE
    K945806 SILICATH ALL SILICONE FOLEY CATHETER