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510(k) Data Aggregation

    K Number
    K091952
    Device Name
    ACTA VESSEL OCCLUSION SYSTEM (VOS)
    Manufacturer
    NFOCUS NEUROMEDICAL, INC.
    Date Cleared
    2010-09-10

    (436 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NFOCUS NEUROMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.
    Device Description
    The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.
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    K Number
    K090918
    Device Name
    NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
    Manufacturer
    NFOCUS NEUROMEDICAL, INC.
    Date Cleared
    2009-07-30

    (120 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    NFOCUS NEUROMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nfocus Neuromedical Echo Distal Access Catheter Vessel is indicated for the introduction of interventional and/or diagnostic devices and fluid infusion into the peripheral, coronary, and neuro vasculature.
    Device Description
    The Echo " Distal Access Catheter is a single-stiffness catheter with an atraumatic tip at the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. The Echo Distal Access Catheter is compatible with introducer sheaths having an inner diameter of 6F or greater. A rotating hemostasis valve with side-arm adapter and a compatible guidewire are required, but not provided with the Echo catheter.
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