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

    INTRAVASCULAR IMAGING SYSTEM/MODIFIED

    K Number: K910281 · Decision May 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    5
    Review Days
    110

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    Basic Information

    Device Name
    INTRAVASCULAR IMAGING SYSTEM/MODIFIED
    K Number
    K910281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intertherapy, Inc.
    Date Received
    January 23, 1991
    Decision Date
    May 13, 1991
    Product Code
    JOP
    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
    JOP Transducer, Ultrasonic

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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
    K900305 INTRAVASCULAR IMAGING SYSTEMS
    K895159 INTRAVASCULAR IMAGING SYSTEM