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

    INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER

    K Number: K912600 · Decision Nov 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    5
    Review Days
    162

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    Basic Information

    Device Name
    INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
    K Number
    K912600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intertherapy, Inc.
    Date Received
    June 10, 1991
    Decision Date
    November 19, 1991
    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 Intertherapy, Inc.

    K Number Device Name
    K913763 INTERPRET(TM) CATHETER LINEAR TRANSLATOR
    K910281 INTRAVASCULAR IMAGING SYSTEM/MODIFIED
    K900305 INTRAVASCULAR IMAGING SYSTEMS
    K895159 INTRAVASCULAR IMAGING SYSTEM