BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    STERILE FOLEY CATHETER

    K Number: K890310 · Decision Nov 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    311

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    Basic Information

    Device Name
    STERILE FOLEY CATHETER
    K Number
    K890310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Kosan Far East Ent. , Ltd.
    Date Received
    January 23, 1989
    Decision Date
    November 30, 1989
    Product Code
    EYC
    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
    EYC Catheter, Upper Urinary Tract

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    Other Clearances by Kosan Far East Ent. , Ltd.

    K Number Device Name
    K890311 KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)