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

    OPTIBOLUS

    K Number: K031339 · Decision Jul 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    74

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    Basic Information

    Device Name
    OPTIBOLUS
    K Number
    K031339
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Inc., Liebel-Flarsheim Business
    Date Received
    April 28, 2003
    Decision Date
    July 11, 2003
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Mallinckrodt Inc., Liebel-Flarsheim Business

    K Number Device Name
    K082212 SYRINGE WITH HANDI-FIL
    K073592 OPTISTAR ELITE INJECTION SYSTEM
    K063503 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
    K042744 OPTIV ANTAGE DH POWER INJECTION SYSTEM
    K022116 ELPH INJECTION SYSTEM
    K984088 OPTISTAR MR INJECTOR SYSTEM
    K963071 ANGIOMAT ILLUMENA