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

    OPTISTAR ELITE INJECTION SYSTEM

    K Number: K073592 · Decision May 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    OPTISTAR ELITE INJECTION SYSTEM
    K Number
    K073592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mallinckrodt Inc., Liebel-Flarsheim Business
    Date Received
    December 20, 2007
    Decision Date
    May 7, 2008
    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
    K063503 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
    K042744 OPTIV ANTAGE DH POWER INJECTION SYSTEM
    K031339 OPTIBOLUS
    K022116 ELPH INJECTION SYSTEM
    K984088 OPTISTAR MR INJECTOR SYSTEM
    K963071 ANGIOMAT ILLUMENA