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niagara niagara slim-cath and brevia short-term curved extension hemodialysis catheters
C.R. Bard
Summary: The Niagara Slim-Cath and Brevia catheters are hemodialysis catheters used for short-term vascular access in patients requiring dialysis. Typically used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K090102 ↗
Decision Date
February 12, 2009
Product Code
MPB
Device Class
Class 2
Evidence
0 studies
The Niagara Slim-Cath and Brevia catheters were cleared through the FDA 510(k) pathway on February 12, 2009, by C.R. Bard. They are classified as Class 2 medical devices.
What It Is
The Niagara Slim-Cath and Brevia catheters are specialized hemodialysis catheters designed for short-term use. They provide temporary vascular access for patients undergoing hemodialysis, allowing for efficient blood flow and dialysis treatment. These catheters are typically inserted into large central veins and feature a curved extension to facilitate placement and patient comfort.
Clinical Applications
These catheters are commonly used in hospital settings, particularly in nephrology and interventional radiology departments. They are suitable for patients with acute kidney injury or those awaiting long-term dialysis access creation. The devices are used in both adult and pediatric populations requiring temporary dialysis access.
Indications for Use
The Niagara Slim-Cath and Brevia catheters are indicated for patients who need temporary vascular access for hemodialysis. This includes individuals with acute kidney failure or those who need dialysis while awaiting a more permanent solution.
Practical Considerations
These catheters come 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. Clinicians should be trained in catheter placement and maintenance.
Frequently Asked Questions
What is the Niagara Slim-Cath and Brevia used for?
These catheters are used for providing temporary vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use these catheters in hospital settings.
What are the FDA-cleared indications?
The catheters are indicated for temporary vascular access in patients requiring hemodialysis.
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.