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510(k) Data Aggregation

    K Number
    K961906
    Device Name
    UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
    Date Cleared
    1996-11-19

    (187 days)

    Product Code
    Regulation Number
    876.5250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRUM MEDSYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. uthe UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.
    Device Description
    The UNI-GARD QUIK CATH™ is a sterile, disposable device composed a introducer with lubricant, drainage catheter and urine of collection bag. The introducer containing the lubricant is pressed into the urethral meates until it stops. The catheter is advanced through the introducer and reservoir of lubricant while perforating the introducer tip to enter the urethra. The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection baq.
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