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

    ACIST INJECTOR SYSTEM, MODEL CL100 H

    K Number: K984058 · Decision Feb 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    21
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    ACIST INJECTOR SYSTEM, MODEL CL100 H
    K Number
    K984058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems
    Date Received
    November 13, 1998
    Decision Date
    February 11, 1999
    Product Code
    IZQ
    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
    IZQ Injector, Contrast Medium, Automatic

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    Other Clearances by Acist Medical Systems

    K Number Device Name
    K132474 CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
    K020892 ACIST GENTOO CONTRAST INJECTION SYSTEM
    K021015 ACIST PLUS 4 ANGIOGRAPHIC CATHETER
    K991103 MODIFICATION TO ACIST CL 100H
    K000013 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
    K993774 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH