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

    INTERPRET(TM) CATHETER LINEAR TRANSLATOR

    K Number: K913763 · Decision Nov 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    INTERPRET(TM) CATHETER LINEAR TRANSLATOR
    K Number
    K913763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intertherapy, Inc.
    Date Received
    August 22, 1991
    Decision Date
    November 20, 1991
    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
    K912600 INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
    K910281 INTRAVASCULAR IMAGING SYSTEM/MODIFIED
    K900305 INTRAVASCULAR IMAGING SYSTEMS
    K895159 INTRAVASCULAR IMAGING SYSTEM