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

    CVIS INSIGHT IMAGING CATHETER

    K Number: K897153 · Decision Mar 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    19
    Review Days
    90

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    Basic Information

    Device Name
    CVIS INSIGHT IMAGING CATHETER
    K Number
    K897153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Imaging Systems, Inc.
    Date Received
    December 26, 1989
    Decision Date
    March 26, 1990
    Product Code
    LYK
    Advisory Committee
    Gastroenterology, Urology
    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
    LYK Angioscope

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    Other Clearances by Cardiovascular Imaging Systems, Inc.

    K Number Device Name
    K970049 BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
    K942231 MICROVIEW II/MICRORAIL II CATHETERS
    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
    Search all 19 clearances from Cardiovascular Imaging Systems, Inc. →