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

    BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING

    K Number: K982840 · Decision Nov 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    432
    Review Days
    89

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    Basic Information

    Device Name
    BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING
    K Number
    K982840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    August 12, 1998
    Decision Date
    November 9, 1998
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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