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

    MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER

    K Number: K050542 · Decision Jul 26, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    4
    Review Days
    146

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    Basic Information

    Device Name
    MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
    K Number
    K050542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Marian Medical, Inc.
    Date Received
    March 2, 2005
    Decision Date
    July 26, 2005
    Product Code
    LJS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Marian Medical, Inc.

    K Number Device Name
    K070048 GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
    K063795 GUARDIANCATHETER-URINARY DRAINAGE CATHETER
    K042112 INFANT FEEDING TUBE