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510(k) Data Aggregation

    K Number
    K023914
    Device Name
    COAXIA FLOCONTROL CATHETER
    Manufacturer
    COAXIA INC
    Date Cleared
    2003-02-21

    (88 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    COAXIA INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.
    Device Description
    The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
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