Search Results
Found 1 results
510(k) Data Aggregation
K Number
K961906Device Name
UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018
Manufacturer
Date Cleared
1996-11-19
(187 days)
Product Code
Regulation Number
876.5250Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1