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centros chronic hemodialysis catheter set
Ash Access Technology
Summary: The centros chronic hemodialysis catheter set is used for vascular access in hemodialysis patients. Key evidence highlights its role in managing end-stage renal disease. Two studies provide insights into mortality risk factors and general dialysis outcomes.
FDA Clearance Information
Pathway
510K
Number
K092597 ↗
Decision Date
November 12, 2009
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The centros chronic hemodialysis catheter set was cleared by the FDA via the 510(k) pathway on November 12, 2009. It is manufactured by Ash Access Technology and classified as a Class 2 device.
What It Is
The centros chronic hemodialysis catheter set is a medical device designed for long-term vascular access in patients undergoing hemodialysis. It facilitates efficient blood flow and dialysis treatment in individuals with end-stage renal disease.
Clinical Applications
This device is commonly used in clinical settings for patients requiring chronic hemodialysis, particularly those with end-stage renal disease. It is essential for maintaining vascular access over extended periods.
Evidence Summary
The available literature includes two studies, one focusing on risk factors for mortality in hemodialysis patients and another on broader dialysis outcomes. These studies span from 2014 to 2024 and include various study types.
Reported Outcomes
Published studies report that end-stage renal disease patients under hemodialysis have a high mortality rate, with factors such as inflammation and nutritional status being significant. The catheter set plays a crucial role in managing these patients by providing reliable vascular access.
Safety Profile
Reported complications include disturbances in erythropoiesis and iron metabolism, as highlighted in the studies. However, specific adverse events related to the catheter set itself were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data specific to the catheter set. Further research is needed to explore long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for centros chronic hemodialysis catheter set?
The device is indicated for providing vascular access in patients undergoing chronic hemodialysis, particularly those with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies have reported high mortality rates in hemodialysis patients, with factors such as inflammation and nutritional status being significant. The catheter set aids in managing these patients.
What complications have been reported?
Reported complications include disturbances in erythropoiesis and iron metabolism, though specific device-related adverse events were not detailed.
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.