Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182463Device Name
Silicone Foley Catheter
Manufacturer
Date Cleared
2019-11-06
(422 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Biosensors International Pte Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation.
Device Description
The Silicone Foley Catheter uses the pressure of the bladder to excrete urine. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid. Foley catheter (2-way) can be used for bladder drainage, and Foley catheter (3-way) also can be used for bladder irrigation. Female type Foley Catheter is equipped with the advancer which can be used instead of tweezers during the catheterization. The Silicone Foley Catheter is for single use, is intended for short-term (less than 14 days) use, and is provided with sterile.
Ask a Question
Ask a specific question about this device
Page 1 of 1