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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 ?
510(k)
Number ?
K073092 ↗
Decision Date ?
January 29, 2008
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients who require dialysis treatment.
- Use as a hemodialysis catheter for withdrawing and returning blood during dialysis.
Clinical Applications
- Temporary or longer-term central venous access for hemodialysis when dialysis access is needed.
- Connection to standard hemodialysis equipment for blood removal, filtration, and return.
- Placement in a large central vein, such as the internal jugular or subclavian vein, when clinically appropriate.
Practical Considerations
- Available models include DE19SH24, DE23SH28, DE27SH32, DE31SH36, and DE35SH40; the appropriate size depends on patient anatomy and the intended catheter length.
- The catheter has two lumens with separated tips intended to support blood withdrawal and return during dialysis.
- Placement generally requires sterile technique and imaging guidance, such as ultrasound and fluoroscopy, to reduce malposition and access-related complications.
- Use with compatible dialysis tubing and equipment according to the device labeling and institutional protocol.
- MRI safety should be verified in the current manufacturer labeling before scanning; do not assume the catheter is MR Safe or MR Conditional based only on its name.
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.