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

    VORTEX EZ VASCULAR ACCESS PORT

    K Number: K050176 · Decision Feb 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    9
    Review Days
    30

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    Basic Information

    Device Name
    VORTEX EZ VASCULAR ACCESS PORT
    K Number
    K050176
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rita Medical Systems, Inc.
    Date Received
    January 26, 2005
    Decision Date
    February 25, 2005
    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 Rita Medical Systems, Inc.

    K Number Device Name
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    K032149 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
    K031926 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)
    K031257 RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
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