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510(k) Data Aggregation

    K Number
    K021130
    Device Name
    SPECATH CENTRAL VENOUS CATHETER KITS
    Manufacturer
    SPECIAL MEDICAL CO. LTD.
    Date Cleared
    2003-01-07

    (273 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECIAL MEDICAL CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SPECATH® Central Venous Catheters are intended for the purpose of providing short term access (less than 30 days) to the vascular system for the infusion of fluids, monitoring of pressures, and/or sampling of blood.
    Device Description
    SPECATH® catheters are polyurethane, radiopaque single or multiple (up to 4) lumen catheters. The size of catheters are from 4 French through 12 French and lengths 10 cm through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches into dedicated extension lines. The extension line hubs are labeled to provide positive identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement using a guide wire and then to infuse fluids. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system. To reduce the chance of complications, the central venous catheter tip should be placed in the superior vena cava above its junction with the right atrium with the distal catheter parallel to the vessel wall. For reference. the distal tip should be positioned at a level above either the azvaos vein or the carina of the trachea whichever is better visualized. The accessories described below will be included in the SPECATH® Central Venous Catheter Kits. Guidewires: The quidewire is used for quiding the catheter through the venous a. system to the desired catheter placement location. According to the different sizes of the catheters, varying size quidewire will be included in the kit: Diameters are 0.018", 0.035"; Lengths are 450mm (45cm), 500 mm (50cm), 700mm (70cm), 1500mm (150 cm), b. Vessel Dialators: Dialators are used to enlarge the introducer path of the catheter. According to the size of the catheter, there will be a corresponding dialator with different size and effective lengths. C. Introducer: The introducer is used for entrance and tunneling into the skin and vascular system for the purpose of catheter placement. According to the size of the catheter, the following introducers will be included: 18 Ga, 70 mm; 19 Ga, 45 mm; 20 Ga, 45 mm. ರ. Syringe: A 5 ml. Svringe manufactured by Becton Dickinson and used to infuse fluids into the catheter will be included in the kit. Injection Caps: The injection cap is connected to the female luer hubs of the e. extension tubes.
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