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

    GUARDIANCATHETER-URINARY DRAINAGE CATHETER

    K Number: K063795 · Decision Mar 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    4
    Review Days
    73

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    Basic Information

    Device Name
    GUARDIANCATHETER-URINARY DRAINAGE CATHETER
    K Number
    K063795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marian Medical, Inc.
    Date Received
    December 22, 2006
    Decision Date
    March 5, 2007
    Product Code
    GBM
    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
    GBM Catheter, Urethral

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    Other Clearances by Marian Medical, Inc.

    K Number Device Name
    K070048 GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
    K050542 MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
    K042112 INFANT FEEDING TUBE