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510(k) Data Aggregation
K Number
K233094Device Name
Wellead® Latex Foley Catheter
Manufacturer
Well Lead Medical (Hainan) Co., Ltd.
Date Cleared
2024-06-06
(254 days)
Product Code
MJC, EYB, EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical (Hainan) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
Device Description
The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
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