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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
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 ?
510(k)
Number ?
K161026 ↗
Decision Date ?
August 9, 2016
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients requiring repeated dialysis treatments.
Clinical Applications
- Providing central venous access for chronic hemodialysis.
- Supporting repeated hemodialysis treatments when a long-term dialysis catheter is clinically indicated.
- Use in adult patients with kidney failure or advanced chronic kidney disease who require ongoing hemodialysis.
Practical Considerations
- Available lengths include 24, 28, 32, 36, 40, and 55 cm; selection depends on patient anatomy, insertion site, and intended tip location.
- Placement is generally performed using imaging guidance, with the catheter tip positioned in a central vein for dialysis access.
- The catheter requires sterile handling, securement, and regular exit-site care to reduce infection, thrombosis, and malfunction risks.
- The FDA record provided does not establish MRI compatibility; MRI safety should be confirmed in the current manufacturer labeling before scanning.
- Contraindications and precautions include active infection at the insertion site, unsuitable central venous anatomy, bleeding risk, and inability to maintain catheter care.
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.