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

    Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

    K Number: K253399 · Decision Oct 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
    K Number
    K253399
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Volcano Corporation (Dba Philips Image Guided Therapy Device
    Date Received
    September 30, 2025
    Decision Date
    October 28, 2025
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OBJ), ordered by most recent decision date.

    Novasight Hybrid System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XC11 ICE System, USA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ViewFlex™ X ICE Catheter, Sensor Enabled™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all