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

    OMNIPICC P.I.

    K Number: K062579 · Decision Nov 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    OMNIPICC P.I.
    K Number
    K062579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rita Medical Systems, Inc.
    Date Received
    August 31, 2006
    Decision Date
    November 28, 2006
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Rita Medical Systems, Inc.

    K Number Device Name
    K070101 UNIBLATE ELECTROSURGICAL DEVICE
    K062414 VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
    K051102 OMNIPICC PI
    K050176 VORTEX EZ VASCULAR ACCESS PORT
    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
    K030936 RITA CLIPS FOR INFUSION PUMPS