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Power Acute Triple Lumen Hemodialysis Catheter
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 ?
510(k)
Number ?
K222170 ↗
Decision Date ?
January 13, 2023
Product Code ?
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
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.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis.
- Use in patients requiring acute or short-term renal replacement therapy.
- Use in adult or pediatric patients when temporary central venous dialysis access is needed, according to the applicable product labeling.
Clinical Applications
- Hemodialysis for patients with acute kidney injury.
- Short-term hemodialysis when permanent dialysis access is unavailable or not yet ready.
- Urgent renal replacement therapy in an acute-care setting.
- Temporary central venous access during a hospitalization for dialysis-dependent renal failure.
Practical Considerations
- Available catheter sizes and lengths should be selected according to patient age, body size, access vessel, prescribed blood-flow requirements, and the specific product instructions.
- The catheter is inserted into a large central vein, commonly the internal jugular or femoral vein; subclavian access may be avoided in patients who may need future permanent dialysis access.
- Insertion should use aseptic technique and appropriate imaging guidance, such as ultrasound and fluoroscopy, when available. Tip position and catheter function should be confirmed according to institutional practice.
- The catheter should be connected only to compatible dialysis equipment and handled according to the manufacturer’s instructions, including lumen flushing, locking, clamping, and dressing care.
- MRI safety depends on the exact catheter model and labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status before an MRI; do not assume that a catheter is MRI safe based only on its name.
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.