BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    HLM TUBING SET WITH BIOLINE COATING

    K Number: K080592 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    20
    Applicant Total
    44
    Review Days
    192

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    Basic Information

    Device Name
    HLM TUBING SET WITH BIOLINE COATING
    K Number
    K080592
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maquet Cardiopulmonary, AG
    Date Received
    March 3, 2008
    Decision Date
    September 11, 2008
    Product Code
    DWE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWE Tubing, Pump, Cardiopulmonary Bypass

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