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nexsite hd hemodialysis step tip catheter 60cm
Marvao Medical Devices
Summary: The NexSite HD Hemodialysis Step Tip Catheter is a 60cm device used for vascular access in hemodialysis patients. It is primarily utilized by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway
510K
Number
K171571 ↗
Decision Date
November 30, 2017
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The NexSite HD Hemodialysis Step Tip Catheter was cleared through the FDA 510(k) pathway on November 30, 2017. Manufactured by Marvao Medical Devices, it is classified as a Class 2 device under product code MSD.
What It Is
The NexSite HD Hemodialysis Step Tip Catheter is a specialized vascular access device designed for hemodialysis. It features a step tip design that facilitates smooth insertion and stable positioning within the vascular system. The 60cm length is suitable for adult patients, providing reliable access to the central venous system for efficient dialysis treatment.
Clinical Applications
This catheter is commonly used in dialysis centers and hospitals for patients requiring long-term hemodialysis. It is typically inserted by nephrologists or interventional radiologists in a sterile environment. The device is suitable for adult patients with chronic kidney disease who need regular dialysis sessions.
Indications for Use
The FDA indications for this device include providing vascular access for hemodialysis in patients with chronic kidney disease. It is intended for patients who require long-term dialysis treatment.
Practical Considerations
The NexSite HD Hemodialysis Step Tip Catheter is available in a 60cm length, making it suitable for most adult patients. It is compatible with standard hemodialysis equipment and requires careful insertion technique to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the NexSite HD Hemodialysis Step Tip Catheter used for?
It is used for providing vascular access in patients undergoing hemodialysis.
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 device is indicated for providing vascular access for hemodialysis in patients with chronic kidney 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.