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

    CRIT-LINE CLIP (CLIC) BLOOD CHAMBER

    K Number: K152953 · Decision Nov 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    42
    Review Days
    29

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    Basic Information

    Device Name
    CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
    K Number
    K152953
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Medical Care North America
    Date Received
    October 7, 2015
    Decision Date
    November 5, 2015
    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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    Other Clearances by Fresenius Medical Care North America

    K Number Device Name
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    K131611 FRESENIUS DRY ACID DISSOLUTION UNITS
    K124035 2008K@HOME HEMODIALYSIS MACHINE
    K121341 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
    K120017 FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
    K113427 FRESENIUS 2008T HEMODIALYSIS MACHINE
    K070049 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
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