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

    INTRAVASCULAR IMAGING SYSTEMS

    K Number: K900305 · Decision Apr 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    INTRAVASCULAR IMAGING SYSTEMS
    K Number
    K900305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Intertherapy, Inc.
    Date Received
    January 21, 1990
    Decision Date
    April 20, 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 Intertherapy, Inc.

    K Number Device Name
    K913763 INTERPRET(TM) CATHETER LINEAR TRANSLATOR
    K912600 INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
    K910281 INTRAVASCULAR IMAGING SYSTEM/MODIFIED
    K895159 INTRAVASCULAR IMAGING SYSTEM