📋 FDA Reference
Niagara Niagara Slim-Cath and Brevia Short-Term Curved Extension Hemodialysis Catheters
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 ?
510(k)
Number ?
K090102 ↗
Decision Date ?
February 12, 2009
Product Code ?
MPB Catheter, Hemodialysis, Non-Implanted
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.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis.
- Use in patients who require short-term extracorporeal blood access for dialysis treatment.
Clinical Applications
- Temporary hemodialysis access in hospitalized patients with acute kidney injury.
- Dialysis access while a patient awaits creation or maturation of a more permanent access, such as an arteriovenous fistula or graft.
- Short-term central venous access for hemodialysis using standard dialysis equipment.
- Placement in a large central vein when temporary dialysis access is clinically required.
Practical Considerations
- The catheter is intended for short-term use; duration depends on the patient's clinical condition, access plan and institutional protocol.
- Available catheter sizes and configurations should be selected according to patient anatomy, prescribed blood-flow requirements and the manufacturer's instructions for use.
- Placement and removal require sterile technique and appropriately trained clinicians. Ultrasound and fluoroscopic or other imaging guidance may be used depending on the access site and clinical setting.
- The catheter must be connected only to compatible hemodialysis equipment and managed according to dialysis and catheter-maintenance protocols.
- MRI safety and conditions are model-specific. Confirm the exact catheter configuration and current manufacturer labeling before an MRI examination; do not assume that the catheter is MRI safe or MRI conditional.
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.