BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

    K Number: K243432 · Decision Jul 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    135
    Review Days
    259

    Basic Information

    Device Name
    Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
    K Number
    K243432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainlab AG
    Date Received
    November 5, 2024
    Decision Date
    July 22, 2025
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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