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

    HEMOBAG, MODEL HBBSD2000

    K Number: K031150 · Decision Jun 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    HEMOBAG, MODEL HBBSD2000
    K Number
    K031150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Global Blood Resources, LLC
    Date Received
    April 10, 2003
    Decision Date
    June 23, 2003
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Global Blood Resources, LLC

    K Number Device Name
    K031151 TS3 TUBING SET