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

    JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900

    K Number: K031346 · Decision Jun 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    55

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    Basic Information

    Device Name
    JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
    K Number
    K031346
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jomed, Inc.
    Date Received
    April 29, 2003
    Decision Date
    June 23, 2003
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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    Other Clearances by Jomed, Inc.

    K Number Device Name
    K031148 IN-VISION IMAGING SYSTEM
    K031277 JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
    K022762 JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
    K021219 SMARTWIRE/SMARTMAP PRESSURE SYSTEM
    K003938 TRAK BACK II