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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 device used for vascular access in hemodialysis patients. Key evidence highlights its role in reducing catheter-related complications.
FDA Clearance Information
Pathway
510K
Number
K141363 ↗
Decision Date
June 18, 2014
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Centros long term hemodialysis catheter was cleared by the FDA through the 510(k) pathway on June 18, 2014. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Centros long term hemodialysis catheter is designed for providing vascular access in patients undergoing hemodialysis. It is intended for long-term use and is inserted into a central vein to facilitate efficient blood flow during dialysis sessions.
Clinical Applications
This catheter is commonly used in patients requiring long-term hemodialysis, particularly when other forms of vascular access, such as arteriovenous fistulas, are not feasible. It is often employed in chronic kidney disease patients who need reliable and sustained access for dialysis.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses. These studies span from 2024 to 2026, providing insights into the catheter's clinical performance and safety profile.
Reported Outcomes
Published studies report that the Centros catheter is effective in maintaining vascular access for hemodialysis with a focus on reducing catheter-related bloodstream infections. The evidence suggests improved patient outcomes in terms of access longevity and reduced intervention rates.
Safety Profile
Reported complications include catheter-related bloodstream infections, which remain a significant concern. However, the studies highlight efforts to mitigate these risks through improved catheter design and prophylactic measures.
Evidence Limitations
The evidence is limited by small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term safety and efficacy, as well as to optimize infection prevention strategies.
Frequently Asked Questions
What are the clinical indications for Centros long term hemodialysis catheter?
The catheter is indicated for providing long-term vascular access in patients undergoing hemodialysis, particularly when other access methods are not suitable.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access with reduced rates of catheter-related complications, particularly infections.
What complications have been reported?
Safety data indicate catheter-related bloodstream infections as a primary complication, with ongoing efforts to reduce these risks.
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.