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Spire Biomedical
Summary: The Decathlon Twin Lumen Hemodialysis catheter is used for hemodialysis in patients requiring renal replacement therapy. It is typically used by nephrologists and dialysis nurses in both acute and chronic settings.
FDA Clearance Information
Pathway 510K
Number K032061 ↗
Decision Date December 23, 2003
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Decathlon Twin Lumen Hemodialysis catheter was cleared via the FDA 510k pathway on December 23, 2003. Manufactured by Spire Biomedical, it is classified as a Class 2 medical device.
What It Is
The Decathlon Twin Lumen Hemodialysis catheter is a medical device designed for vascular access in patients undergoing hemodialysis. It features two lumens with separated tips, allowing for efficient blood flow during dialysis sessions. The catheter is inserted into a central vein, providing a conduit for blood to be removed, filtered, and returned to the body.
Clinical Applications
This catheter is commonly used in nephrology for patients with end-stage renal disease (ESRD) or acute kidney injury (AKI) requiring dialysis. It is suitable for use in hospital settings, dialysis centers, and sometimes in home dialysis setups. The device is particularly useful for patients who need temporary vascular access or those awaiting more permanent solutions like arteriovenous fistulas.
Indications for Use
The Decathlon catheter is indicated for use in patients who require hemodialysis, typically those with compromised kidney function. It is used to facilitate the removal and return of blood during dialysis treatments.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and clinical needs. Proper insertion technique is crucial to minimize complications such as infection or thrombosis. Compatibility with standard dialysis machines is ensured.
Frequently Asked Questions
What is the Decathlon Twin Lumen Hemodialysis catheter used for?
It is used for providing vascular access for hemodialysis in patients with renal failure.
What specialties typically use this device?
Nephrologists and dialysis nurses commonly use this device in various clinical settings.
What are the FDA-cleared indications?
It is indicated for use in patients requiring hemodialysis, typically those with 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.