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centros long-term hemodialysis catheter centrosflo long-term hemodialysis catheter
Merit Medical Systems
Summary: The Centros Long-Term Hemodialysis Catheter is a medical device used for providing vascular access for hemodialysis in patients with kidney failure. It is typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway
510K
Number
K151967 ↗
Decision Date
April 4, 2016
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Centros Long-Term Hemodialysis Catheter, manufactured by Merit Medical Systems, was cleared through the FDA 510(k) pathway on April 4, 2016. It is classified as a Class 2 device under product code MSD.
What It Is
The Centros Long-Term Hemodialysis Catheter is a specialized catheter designed for long-term vascular access in patients requiring hemodialysis. It is inserted into a large central vein, typically the internal jugular or subclavian vein, to facilitate efficient blood flow during dialysis sessions. The catheter's design helps minimize complications such as thrombosis and infection, which are common in long-term vascular access devices.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease who require regular hemodialysis treatments. It is typically utilized in hospital settings, dialysis centers, and sometimes in home dialysis setups. Nephrologists and interventional radiologists are the primary specialists involved in the insertion and management of these catheters, ensuring that patients have reliable and safe access for their dialysis needs.
Indications for Use
The FDA-cleared indications for this device include providing long-term vascular access for hemodialysis in patients with end-stage renal disease. It is intended for use in patients who require ongoing dialysis treatments and do not have suitable arteriovenous fistulas or grafts.
Practical Considerations
The Centros catheter is available in various sizes to accommodate different patient anatomies and dialysis flow requirements. It is compatible with standard dialysis equipment and requires careful insertion technique to minimize the risk of complications. Regular monitoring and maintenance are essential to ensure the catheter remains functional and free from infection.
Frequently Asked Questions
What is the Centros Long-Term Hemodialysis Catheter used for?
It is used to provide long-term vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for providing long-term vascular access for hemodialysis in patients with 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.