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510(k) Data Aggregation

    K Number
    K191512
    Device Name
    LotusCatheter (Lotus No Balloon Catheter)
    Manufacturer
    Hakki Medical Technologies, Inc.
    Date Cleared
    2020-05-21

    (349 days)

    Product Code
    GBM, CLA, FEW
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hakki Medical Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.
    Device Description
    The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.
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    K Number
    K101900
    Device Name
    HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
    Manufacturer
    HAKKI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2011-02-07

    (215 days)

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

    HAKKI MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.
    Device Description
    The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra and is an improved version of the straight urinary catheter. The Hakki catheter has built-in expandable/retractable Malecot type wings permitting holding capabilities less than that of a Foley catheter, but allows greater holding power than a straight catheter. By design the Hakki catheter has the ability to maximize drainage of a bladder, due to the location of its drainage opening at the natural drainage point within the bladder. The Hakki catheter is activated by expanding and contracting the catheter through the built-in patented bellows, which open and close the wing tip. The newly designed Hakki urinary catheter functions in the same manner as a straight or Foley catheter and is inserted through the urethra into the bladder.
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