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nexsite hd 55cm hemodialysis catheter for long term use
Marvao Medical Devices
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 510K
Number K140492 ↗
Decision Date November 13, 2014
Product Code MSD
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.
Clinical Applications
This catheter is commonly used in chronic kidney disease patients who require ongoing hemodialysis treatments. It is typically inserted in hospital or outpatient settings by nephrologists or interventional radiologists. The device is particularly useful for patients who have exhausted other forms of vascular access or are awaiting more permanent solutions like AV fistulas.
Indications for Use
The NexSite HD 55cm Hemodialysis Catheter is indicated for patients needing long-term hemodialysis access. It is suitable for those with chronic kidney failure who require regular dialysis sessions to manage their condition.
Practical Considerations
The 55cm length is suitable for most adult patients, ensuring proper placement in central veins. Clinicians should ensure compatibility with the patient's anatomy and consider ultrasound guidance for insertion to minimize complications. Regular monitoring for signs of infection or thrombosis is recommended.
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.