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

    CAREline Airless Hemodialysis Blood Tubing Sets

    K Number: K172238 · Decision Dec 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    181
    Applicant Total
    36
    Review Days
    141

    Basic Information

    Device Name
    CAREline Airless Hemodialysis Blood Tubing Sets
    K Number
    K172238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care Renal Therapies Group, LLC
    Date Received
    July 26, 2017
    Decision Date
    December 14, 2017
    Product Code
    KOC
    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
    KOC Accessories, Blood Circuit, Hemodialysis

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