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decathlon twin lumen hemodialysis catheter with separated tips models de19sh24 de23sh28 de27sh32 de31sh36 de35sh40
Spire Biomedical
Summary: The Decathlon Twin Lumen Hemodialysis Catheter is a medical device used for hemodialysis in patients requiring dialysis access. It is typically used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway 510K
Number K073092 ↗
Decision Date January 29, 2008
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Decathlon Twin Lumen Hemodialysis Catheter by Spire Biomedical was cleared via the FDA 510(k) pathway on January 29, 2008. It is a Class 2 medical device.
What It Is
The Decathlon Twin Lumen Hemodialysis Catheter is designed to provide vascular access for hemodialysis. It features separated tips to optimize blood flow and reduce recirculation during dialysis sessions. The catheter is inserted into a large vein, typically in the neck or chest, allowing for efficient blood filtration and waste removal.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease who require regular hemodialysis. It is typically placed by nephrologists or interventional radiologists in hospital settings or specialized dialysis centers. The device is suitable for both temporary and longer-term use, depending on the patient's vascular access needs.
Indications for Use
The catheter is indicated for use in patients who need hemodialysis due to kidney failure. It provides a reliable means of accessing the bloodstream for dialysis treatment, which is essential for patients with end-stage renal disease.
Practical Considerations
The Decathlon catheter comes in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis equipment and requires careful insertion technique to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the Decathlon Twin Lumen Hemodialysis Catheter used for?
It is used to provide vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for hemodialysis in patients requiring dialysis access due to kidney failure.
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.