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

    CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL

    K Number: K921631 · Decision Jul 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    19
    Review Days
    87

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    Basic Information

    Device Name
    CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL
    K Number
    K921631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardiovascular Imaging Systems, Inc.
    Date Received
    April 6, 1992
    Decision Date
    July 2, 1992
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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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
    K921148 CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE
    K921147 CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE
    Search all 19 clearances from Cardiovascular Imaging Systems, Inc. →