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baxter arena hemodialysis delivery system model 1571278000
Baxter Healthcare
Summary: The Baxter Arena Hemodialysis Delivery System is a device used for hemodialysis treatment. It is primarily used in patients requiring renal replacement therapy. Key evidence includes studies on kidney outcomes in heart failure patients.
FDA Clearance Information
Pathway
510K
Number
K030099 ↗
Decision Date
June 17, 2003
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Baxter Arena Hemodialysis Delivery System was cleared by the FDA via the 510k pathway on June 17, 2003. It is manufactured by Baxter Healthcare and is classified as a Class 2 device.
What It Is
The Baxter Arena Hemodialysis Delivery System is a medical device designed for hemodialysis, a process that removes waste products and excess fluid from the blood when the kidneys are not functioning properly. It is intended for use in patients with end-stage renal disease or acute kidney injury.
Clinical Applications
This device is commonly used in clinical settings for patients requiring renal replacement therapy, particularly those with chronic kidney disease or acute kidney injury. It is utilized in both hospital and outpatient dialysis centers.
Evidence Summary
The available literature includes two studies focusing on kidney outcomes in heart failure patients, published between 2021 and 2024. These studies include retrospective analyses and provide insights into kidney function and outcomes.
Reported Outcomes
Published studies report on kidney outcomes in patients hospitalized with heart failure, highlighting the importance of monitoring kidney function in this population. However, specific efficacy findings related to the device itself are not detailed in the provided evidence.
Safety Profile
Reported complications include general concerns associated with hemodialysis, such as hypotension and vascular access issues. The provided studies do not specify device-related adverse events.
Evidence Limitations
The evidence provided does not directly evaluate the Baxter Arena Hemodialysis Delivery System, focusing instead on broader kidney outcomes in heart failure patients. Further research is needed to assess device-specific efficacy and safety.
Frequently Asked Questions
What are the clinical indications for Baxter Arena Hemodialysis Delivery System?
The device is indicated for use in patients requiring hemodialysis due to end-stage renal disease or acute kidney injury.
What outcomes have been reported in clinical studies?
Studies report on kidney outcomes in heart failure patients, but specific outcomes related to the device are not detailed.
What complications have been reported?
Safety data from evidence includes general hemodialysis complications such as hypotension and vascular access issues.
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.