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power acute triple lumen hemodialysis catheter
Health Line International
Summary: The Power Acute Triple Lumen Hemodialysis Catheter is a medical device used for hemodialysis in patients requiring renal replacement therapy. It is typically used by nephrologists and dialysis nurses in hospital or dialysis center settings.
FDA Clearance Information
Pathway
510K
Number
K222170 ↗
Decision Date
January 13, 2023
Product Code
NIE
Device Class
Class 2
Evidence
0 studies
The Power Acute Triple Lumen Hemodialysis Catheter received FDA 510k clearance on January 13, 2023. Manufactured by Health Line International, it is classified as a Class 2 device under product code NIE.
What It Is
The Power Acute Triple Lumen Hemodialysis Catheter is a specialized catheter designed for acute hemodialysis. It features three lumens, allowing for efficient blood flow and medication administration. The catheter is inserted into a large central vein, providing temporary vascular access for patients with acute kidney failure or those requiring short-term dialysis.
Clinical Applications
This catheter is commonly used in acute care settings, such as hospitals, where patients require urgent dialysis due to acute kidney injury or other conditions leading to renal failure. It is typically utilized by nephrologists and dialysis nurses. The device is suitable for adult and pediatric patients who need temporary vascular access for hemodialysis.
Indications for Use
The catheter is indicated for use in patients who need temporary vascular access for hemodialysis. This includes individuals with acute kidney injury or those who require short-term dialysis due to other medical conditions.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis equipment and should be inserted using aseptic technique to minimize infection risk. Proper positioning and securement are essential to ensure optimal function and patient safety.
Frequently Asked Questions
What is the Power Acute Triple Lumen Hemodialysis Catheter used for?
It is used for providing temporary vascular access for hemodialysis in patients with acute kidney injury or requiring short-term dialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital or dialysis center settings typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for temporary vascular access for hemodialysis in patients with acute kidney injury or requiring short-term dialysis.
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.