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

    ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

    K Number: K980919 · Decision Mar 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    6
    Review Days
    20

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    Basic Information

    Device Name
    ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
    K Number
    K980919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fortune Medical Instrument Corp.
    Date Received
    March 11, 1998
    Decision Date
    March 31, 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 Fortune Medical Instrument Corp.

    K Number Device Name
    K022112 FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
    K021193 FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
    K021142 ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
    K014002 ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
    K980917 ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR