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510(k) Data Aggregation

    K Number
    K032710
    Device Name
    CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
    Manufacturer
    APOGEE MEDICAL, INC.
    Date Cleared
    2004-01-09

    (129 days)

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

    APOGEE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
    Device Description
    The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated catheter contained in a sterile collection bag. The Closed System Intermittent Catheter is intended to be user to drain urine from the bladder. When it is not practical or feasible for the patient to drain the bladder into a commode or bedpan, the urine may be drained into the collection bag of the Closed System Intermittent Catheterization Kit. The Closed System Intermittent Catheterization Kit is designed with a collection bag and introducer which provide the mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter, thereby, reducing possibility of contamination.
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    K Number
    K011552
    Device Name
    UROLOGICAL CATHETER
    Manufacturer
    APOGEE MEDICAL, INC.
    Date Cleared
    2001-07-18

    (61 days)

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

    APOGEE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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