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510(k) Data Aggregation

    K Number
    K013276
    Device Name
    ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)
    Manufacturer
    SEWOON MEDICAL CO., LTD.
    Date Cleared
    2002-02-15

    (137 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEWOON MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.
    Device Description
    The Sewoon Medical Device Corp. Ltd. catheter has a tube with a single drainage eye on the proximal tip. The catheter has an additional eye for irrigation purposes. The catheters are available with a radiopaque option. The catheter is available in a combination of French sizes, capacities and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths are 29 and 41 cm. French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.
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