📋 FDA Reference
Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 19cm Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 23cm Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 27cm Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 31cm Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 35cm Nexsite HD Hemodialysis Symmetric Tip Catheter for Long Term Use 55cm
Summary: The NexSite HD Hemodialysis Catheter is a long-term vascular access device used for hemodialysis. It is typically utilized by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K173805 ↗
Decision Date ?
February 8, 2018
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NexSite HD Hemodialysis Catheter was cleared via the FDA 510k pathway on February 8, 2018. Manufactured by Marvao Medical Devices, it is classified as a Class 2 medical device.
What It Is
The NexSite HD Hemodialysis Catheter is a tunneled, symmetric tip catheter designed for long-term vascular access in patients requiring hemodialysis. It is available in various lengths, from 19cm to 55cm, to accommodate different patient anatomies. The catheter's design aims to optimize blood flow and minimize complications such as thrombosis and infection.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients who require dialysis treatment.
- Use in patients with chronic kidney disease or end-stage renal disease who need regular hemodialysis.
Clinical Applications
- Providing temporary or longer-term central venous access for repeated hemodialysis treatments.
- Hemodialysis access when an arteriovenous fistula or graft is not available, not mature, or cannot be used.
- Tunneled catheter placement through a central vein for ongoing dialysis access.
- Use in adult or pediatric patients when the selected catheter length is appropriate for the patient's anatomy.
Practical Considerations
- Available catheter lengths include 19, 23, 27, 31, 35, and 55 cm; selection should be based on the access vein, tunnel course, body habitus, and catheter-tip position.
- Placement is generally performed using sterile technique and imaging guidance, commonly through the internal jugular vein; femoral or other central venous access may be considered according to the patient's anatomy and clinical situation.
- The catheter must be compatible with the dialysis circuit and handled according to the manufacturer's instructions, including lumen priming, flushing, locking, and maximum flow-rate guidance.
- Monitor for catheter-related bloodstream infection, thrombosis, fibrin sheath, poor blood flow, malposition, and central venous stenosis.
- MRI safety should be confirmed in the current manufacturer labeling and institutional policy before scanning; do not assume that an implanted dialysis catheter is universally MR safe or MR conditional.
Frequently Asked Questions
What is the NexSite HD Hemodialysis 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, interventional radiologists, and vascular surgeons typically use this device in clinical practice.
What are the FDA-cleared indications?
The catheter is indicated for long-term hemodialysis access in patients with chronic kidney disease or end-stage renal disease.
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.