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510(k) Data Aggregation
K Number
K961697Device Name
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
Manufacturer
MEDICAL DEVICE INTL., INC.
Date Cleared
1996-08-30
(120 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPTICON™ Female Uninary Catheter for Continuous Drainage is used to pass fluids from the urinary bladder. It must be connected to standard drainage tubes, drainage rube adaptors, tubes and bags.
Device Description
The OPTICON™ Female Urinary Catheter for Continuous Drainage is a sterile, single use/disposable, flexible, tubular device that is inserted through the urethra and is used to pass urine from the uningry tract when connected to standard drainage tube adaptors, tubes and bags. The catheter is manufactured from soft biocompatible silicone and comes in only one size (18 French) and leagth, 10.8 cm (4.3 inches). When inserted, all that is visible ouside of the body is a microvalve for balloon inflation and retainer ring. The device is to be used only with standard urinary drainage tube adaptors, tubes and bags.
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