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510(k) Data Aggregation

    K Number
    K070212
    Device Name
    CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)
    Manufacturer
    OVALUM LTD.
    Date Cleared
    2007-10-12

    (263 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    OVALUM LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CiTop™ Guidewire is intended for use in angiographic procedures to facilitate the intra-luminal placement of the wire beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
    Device Description
    The CiTop™ Guidewire has an outside diameter of 0.014" (0.36 mm) and a length of 280 cm. The CiTop™ 0.014" Guidewire can be torqued to facilitate navigation through the vasculature. A handle control is supplied with the guidewire to facilitate torque and tip shaping for deployment and positioning according to standard practices. The distal tip can be momentarily shaped into an arched formation by the operator to aid in releasing a wedged guidewire and allow its advancement through difficult occlusions. A platinum marker coil at the distal tip aids visualization under fluoroscopy. The CiTop™ Guidewire is supported by a stainless steel helical cut accessory shaft with an outside diameter of 0.023" and length of 126cm. The support accessory may be independently torqued and its distal end shaped. The support accessory operates as an aid in the advancement of the CiTop™ Guidewire and as an adjustment to the flexibility of the distal end of the CiTop™ Guidewire . The CiTop™ 0.014" Guidewire is supplied in a protective dispenser, that is packaged in a single-use sterilizeable pouch. The Pouch is labeled, and placed in an individual protective carton for sterilization. The CiTop™ 0.014" Guidewire is a single use/disposable product with a nitinol shaped tip. The Guidewire is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small-diameter, tortuous vasculature.
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