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

    MICROVIEW II/MICRORAIL II CATHETERS

    K Number: K942231 · Decision Aug 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    19
    Review Days
    87

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    Basic Information

    Device Name
    MICROVIEW II/MICRORAIL II CATHETERS
    K Number
    K942231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiovascular Imaging Systems, Inc.
    Date Received
    May 6, 1994
    Decision Date
    August 1, 1994
    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 Cardiovascular Imaging Systems, Inc.

    K Number Device Name
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    K933517 AUTOMATIC PULL BACK DEVICE
    K930232 CVIS INSIGHT IMAGING GUIDE CATHETER
    K924922 CVIS INSIGHT IMAGING CATHETER
    K930311 CVIS LONGVIEW
    K921879 CBIS CATHETER PULL-BACK DEVICE
    K921750 CVIS INSIGHT III SYSTEM
    K921631 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
    K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
    K921147 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
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