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

    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port

    K Number: K252478 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    21
    Review Days
    29

    Basic Information

    Device Name
    Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port
    K Number
    K252478
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Access Systems, Inc.
    Date Received
    August 7, 2025
    Decision Date
    September 5, 2025
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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    Other Clearances by Bard Access Systems, Inc.

    K Number Device Name
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    K240146 BD Prevue™ II Peripheral Vascular Access System
    K222232 Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
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    K120882 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
    K100402 SITE-RITE VISION ULTRASOUND SYSTEM
    K071095 ASPIRA PLEURAL DRAINAGE SYSTEM
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