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

    CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

    K Number: K242429 · Decision Apr 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    237

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    Basic Information

    Device Name
    CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
    K Number
    K242429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Inc. (Bd)
    Date Received
    August 15, 2024
    Decision Date
    April 9, 2025
    Product Code
    SEF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SEF Central Venous Catheter With Manual Insertion System