BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Novasight Hybrid System

    K Number: K252945 · Decision Apr 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    3
    Review Days
    214

    Basic Information

    Device Name
    Novasight Hybrid System
    K Number
    K252945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conavi Medical, Inc.
    Date Received
    September 15, 2025
    Decision Date
    April 17, 2026
    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 Conavi Medical, Inc.

    K Number Device Name
    K172258 Novasight Hybrid System
    K162789 Foresight Intracardiac Echocardiology (ICE) System