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

    Reconnaissance PV .018 OTW Digital IVUS Catheter

    K Number: K200410 · Decision May 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    4
    Review Days
    93

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    Basic Information

    Device Name
    Reconnaissance PV .018 OTW Digital IVUS Catheter
    K Number
    K200410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Image Guided Therapy Corporation
    Date Received
    February 19, 2020
    Decision Date
    May 22, 2020
    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 Philips Image Guided Therapy Corporation

    K Number Device Name
    K253714 IntraSight Plus
    K251103 VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
    K200812 VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter