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510(k) Data Aggregation
K Number
K080878Device 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
876.5130Why 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
K973120Device Name
READYCATH CATHETER
Manufacturer
MEDICAL TECHNOLOGIES OF GEORGIA
Date Cleared
1998-02-25
(189 days)
Product Code
GBM
Regulation Number
876.5130Why 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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