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

    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

    K Number: K070048 · Decision Mar 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    4
    Review Days
    71

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    Basic Information

    Device Name
    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
    K Number
    K070048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marian Medical, Inc.
    Date Received
    January 3, 2007
    Decision Date
    March 15, 2007
    Product Code
    FCM
    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
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

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    Other Clearances by Marian Medical, Inc.

    K Number Device Name
    K063795 GUARDIANCATHETER-URINARY DRAINAGE CATHETER
    K050542 MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
    K042112 INFANT FEEDING TUBE