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disposable hemodialysis access catheter sets
Foshan Nanhai Bai He Medical Technology
Summary: Disposable hemodialysis access catheter sets are used for vascular access in patients undergoing hemodialysis. Typically used by nephrologists and dialysis nurses, these devices facilitate efficient blood filtration.
FDA Clearance Information
Pathway
510K
Number
K102833 ↗
Decision Date
November 18, 2011
Product Code
MPB
Device Class
Class 2
Evidence
0 studies
The disposable hemodialysis access catheter sets by Foshan Nanhai Bai He Medical Technology were cleared through the FDA 510k pathway on November 18, 2011. They are classified as Class 2 devices under product code MPB.
What It Is
These catheter sets are designed to provide temporary vascular access for patients undergoing hemodialysis. They consist of a catheter that is inserted into a large vein, allowing for the removal and return of blood to the body during dialysis. The device is crucial for patients with kidney failure who require regular dialysis sessions to filter waste products from their blood.
Clinical Applications
These catheters are commonly used in nephrology and dialysis centers for patients with end-stage renal disease. They are typically employed in hospital settings or outpatient dialysis clinics. The device is essential for patients who do not have a permanent arteriovenous fistula or graft, providing a temporary solution for vascular access.
Indications for Use
The FDA-cleared indications for these catheter sets include providing temporary vascular access for hemodialysis in patients with kidney failure. They are suitable for patients who require immediate dialysis access and do not have a permanent access site.
Practical Considerations
These catheters are available in various sizes to accommodate different patient anatomies and are compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is disposable hemodialysis access catheter sets used for?
They are used to provide temporary vascular access for patients undergoing hemodialysis, facilitating blood filtration.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital settings or outpatient dialysis clinics typically use these devices.
What are the FDA-cleared indications?
The device is indicated for temporary vascular access in patients requiring hemodialysis, particularly those without permanent access sites.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.