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nexsite hd hemodialysis step tip catheter for long term use 24 cm 28 cm 32 cm 36 cm 40 cm 55 cm
Marvao Medical Devices
Summary: The NexSite HD Hemodialysis Step Tip Catheter is a long-term vascular access device used for hemodialysis. It is typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway
510K
Number
K161026 ↗
Decision Date
August 9, 2016
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The NexSite HD catheter by Marvao Medical was cleared through the FDA 510(k) pathway on August 9, 2016. It is a Class 2 device under product code MSD.
What It Is
The NexSite HD Hemodialysis Step Tip Catheter is a specialized catheter designed for long-term hemodialysis access. It features a step-tip design intended to optimize flow and reduce complications associated with dialysis. Available in multiple lengths, it provides flexibility for different patient anatomies and clinical needs.
Clinical Applications
This catheter is commonly used in patients requiring long-term hemodialysis, often managed by nephrologists in outpatient dialysis centers or hospital settings. It is suitable for patients with chronic kidney disease who need reliable vascular access for regular dialysis sessions. The device is also used in patients awaiting kidney transplantation.
Indications for Use
The NexSite HD catheter is indicated for patients who require long-term vascular access for hemodialysis. It is suitable for adults with chronic kidney disease needing regular dialysis treatments.
Practical Considerations
The catheter comes in various lengths from 24 cm to 55 cm, allowing for customization based on patient size and vascular anatomy. It is important to ensure proper placement and securement to minimize infection risk and maintain patency.
Frequently Asked Questions
What is the NexSite HD catheter used for?
It is used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and dialysis specialists typically use this device in both outpatient and inpatient settings.
What are the FDA-cleared indications?
The catheter is indicated for long-term hemodialysis access in patients requiring regular dialysis treatments.
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.