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510(k) Data Aggregation

    K Number
    K964757
    Device Name
    CONTIDRAIN CATHETER
    Manufacturer
    CONTIMED, INC.
    Date Cleared
    1997-06-25

    (210 days)

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

    CONTIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ContiDrain™ Catheter is indicated for continuous urine drainage.
    Device Description
    The ContiDrain™ Catheter is an indwelling urinary catheter with the same indication for use and function as a conventional Foley catheter. Like a Foley catheter, the ContiDrain™ Catheter is indicated for continuous urine drainage. Both devices use a tubular catheter to pass urine from the bladder through the urethra and meatus into a urinary drainage bag. Both devices also have a mechanism for retention in the bladder. The ContiDrain™ Catheter has two design features that are different from the conventional Foley catheter. The ContiDrain™ Catheter incorporates two design features found in conventional ureteral stents. These features involve the methods of urine flow and of retention in the bladder.
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