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510(k) Data Aggregation

    K Number
    K990509
    Device Name
    OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
    Manufacturer
    IMPLEMED, INC.
    Date Cleared
    1999-05-18

    (89 days)

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

    IMPLEMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OLIGON™ FOLEY CATHETER is used to pass fluids to or from the urinary tract.
    Device Description
    The OLIGON™ FOLEY CATHETER is an all silicone, dual lumen Folcy catheter (manufactured for Implemed, Inc. by Kendall I Icalthcare Products Company) which has been coated with Implemed's proprietary OLIGON'IM matcrial. The OLIGON™ coating is a patented silver based coating which has been shown in laboratory testing to actively release silver ions when exposed to saline. Under these test conditions, the 16 Fr catheters (91 cnt surface area) released a total of 3,4 milligrams of silver over 28 days and the 18 Fr catheters (96 cm2 surface arca) would release a total of 3.6 milligrams of silver over 28 days. The OLIGON™ FOLEY CATHETER is supplied in two sizes; 16 Fr. and 18 Fr. (outer diameler). OLIGON™ Folcy catheters are supplied storile for single use. Individual catheters are packaged in sterilizable Tyvek/mylar pouches.
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