📋 FDA Reference
Nexsite HD Hemodialysis Step Tip Catheter 60cm
Marvao Medical Devices Limited
Product: NexSite HD Hemodialysis Catheter — all models and sizes · Where to buy
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 ?
510(k)
Number ?
K171571 ↗
Decision Date ?
November 30, 2017
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients who require dialysis treatment.
- Use as an implanted hemodialysis catheter for central venous access.
Clinical Applications
- Providing central venous access for maintenance hemodialysis.
- Supporting repeated dialysis treatments in patients who need an implanted hemodialysis catheter.
- Use in adult patients when a tunneled central venous dialysis catheter is selected for vascular access.
Practical Considerations
- The listed catheter length is 60 cm; the appropriate length and tip position depend on the patient's anatomy and selected venous access route.
- Placement is performed using sterile technique, typically with ultrasound and fluoroscopic or other imaging guidance, by trained clinicians.
- The catheter must connect to compatible hemodialysis bloodlines and equipment according to the manufacturer's instructions.
- Important risks include bleeding, infection, thrombosis, catheter malfunction, air embolism and injury to nearby structures.
- MRI safety information is device-specific and is not provided in the FDA record supplied here; consult the current manufacturer labeling before MRI.
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.