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510(k) Data Aggregation

    K Number
    K080878
    Device Name
    MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
    Manufacturer
    MEDICAL TECHNOLOGIES OF GEORGIA, INC.
    Date Cleared
    2008-07-17

    (108 days)

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

    MEDICAL TECHNOLOGIES OF GEORGIA, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTG fustant Cath™, MTG firstant Cath™ 'title (f VF or BZK), MTG finstant Cath 'M Detuxe and MTG Tinstant Cath™ Deluxe kit (PVP or BZK) are intended to be used to drain urine from the patient's bladder.
    Device Description
    The MTG Instant Cath™ is a sterile, closed system, single use, disposable, pre-lubricated PVC or Red Rubber (based on user preference for softness both are offered) catheter self-contained in a collection bag. It is used 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. The MTG Instant Cath™ is designed with a collection bag and introducer tip for inserting the catheter without having to directly touch the catheter. reducing the possibility of contamination. The MTG Instant Cath 100 Deluxe is the same as the MTG Instant Cath", and includes an easy advancer that will make it less likely for the catheter to slip back into the bag during insertion. The purpose of this easy advancer, which does not come in contact with the patient, is solely to make the device casier for the patient or caregiver to advance the catheter and will in no way affect safety or effectiveness of the device. The MTG Instant Cath™ kit and MTG Instant Cath™ Deluxe kit include the intermittent catheter, with either PVP swabs and/or BZK prep pad/swab, gloves, gauze and an underpad. These roducts will be available in various sizes to accommodate a wide range of male, female and pediatric users.
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    K Number
    K973120
    Device Name
    READYCATH CATHETER
    Manufacturer
    MEDICAL TECHNOLOGIES OF GEORGIA
    Date Cleared
    1998-02-25

    (189 days)

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

    MEDICAL TECHNOLOGIES OF GEORGIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMG InstantCath Pre-lubricated Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.
    Device Description
    Not Found
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