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

    ACIST PLUS 4 ANGIOGRAPHIC CATHETER

    K Number: K021015 · Decision Apr 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    ACIST PLUS 4 ANGIOGRAPHIC CATHETER
    K Number
    K021015
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acist Medical Systems
    Date Received
    March 29, 2002
    Decision Date
    April 26, 2002
    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 Acist Medical Systems

    K Number Device Name
    K132474 CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER
    K020892 ACIST GENTOO CONTRAST INJECTION SYSTEM
    K991103 MODIFICATION TO ACIST CL 100H
    K000013 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
    K993774 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
    K984058 ACIST INJECTOR SYSTEM, MODEL CL100 H