đź“‹ 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
Marvao Medical Devices
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
510K
Number
K173805 ↗
Decision Date
February 8, 2018
Product Code
MSD
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.
Clinical Applications
This catheter is primarily used in the management of patients with end-stage renal disease who require regular hemodialysis. It is commonly placed by interventional radiologists or surgeons in a hospital or outpatient setting. The device is suitable for adult and pediatric patients who need long-term dialysis access.
Indications for Use
The NexSite HD Catheter is indicated for patients who require long-term hemodialysis access. It is designed for those with chronic kidney disease or end-stage renal disease who need regular dialysis treatments.
Practical Considerations
When selecting a catheter size, consider the patient's body habitus and vascular anatomy. Ensure compatibility with dialysis machines and follow aseptic techniques during insertion to reduce infection risk. Regular monitoring for signs of infection or malfunction is recommended.
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.