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Nexsite HD 55cm Hemodialysis Catheter for Long Term Use
Summary: The NexSite HD 55cm Hemodialysis Catheter is a long-term hemodialysis access device used primarily in patients requiring regular dialysis. It is typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140492 ↗
Decision Date ?
November 13, 2014
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NexSite HD 55cm Hemodialysis Catheter was cleared through the FDA 510(k) pathway on November 13, 2014. Manufactured by Marvao Medical Devices, it is classified as a Class 2 device under product code MSD.
What It Is
The NexSite HD 55cm Hemodialysis Catheter is a medical device designed for long-term vascular access in patients undergoing hemodialysis. It is inserted into a central vein, usually the internal jugular, and provides a reliable conduit for blood to be drawn from and returned to the patient's circulatory system during dialysis sessions. The catheter's design aims to minimize infection risk and improve patient comfort.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients who require hemodialysis and need a central venous dialysis catheter.
Clinical Applications
- Providing access for repeated hemodialysis treatments.
- Use as long-term dialysis access when an arteriovenous fistula or graft is not available, mature, or suitable.
- Placement through a central vein, commonly the internal jugular vein, for blood withdrawal and return during dialysis.
Practical Considerations
- The 55 cm length must be matched to the patient's height, anatomy, access vein, and intended catheter tip position; it is not suitable for every patient.
- Placement generally uses ultrasound and fluoroscopic or other radiographic guidance, with local anesthesia and moderate sedation when appropriate.
- The catheter must be compatible with the dialysis machine, connectors, anticoagulation or locking solution, and the patient's treatment plan.
- Potential complications include infection, bloodstream infection, thrombosis, bleeding, catheter malfunction, vessel injury, and malposition.
- MRI safety and conditional-use information should be confirmed in the current manufacturer instructions for use; do not assume the catheter is safe for MRI based only on its name.
Frequently Asked Questions
What is NexSite HD 55cm Hemodialysis Catheter used for?
It is used for providing long-term vascular access in patients requiring regular hemodialysis treatments.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The catheter is indicated for long-term hemodialysis access in patients with chronic kidney failure.
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.