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

    ORIGEN DUAL LUMEN CATHETER

    K Number: K003288 · Decision Jun 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    4
    Review Days
    231

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    Basic Information

    Device Name
    ORIGEN DUAL LUMEN CATHETER
    K Number
    K003288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Origen Biomedical, Inc.
    Date Received
    October 20, 2000
    Decision Date
    June 8, 2001
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Origen Biomedical, Inc.

    K Number Device Name
    K113869 ORIGEN REINFORCED DUAL LUMEN CATHETER
    K021702 CRYOBAG, MODEL CB
    K003145 ORIGEN BLADDER HOLDER