BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PHYCON ALL SILICONE BALLOON CATHETER

    K Number: K894883 · Decision Apr 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    7
    Review Days
    267

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    Basic Information

    Device Name
    PHYCON ALL SILICONE BALLOON CATHETER
    K Number
    K894883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vitaid, Ltd.
    Date Received
    August 1, 1989
    Decision Date
    April 25, 1990
    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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