đź“‹ FDA Reference
Decathlon Twin Lumen Hemodialysis with Separated TIPS Models DE19 24sh DE23 28sh DE27 32sh De 31 36sh DE19 24nh
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 ?
510(k)
Number ?
K032061 ↗
Decision Date ?
December 23, 2003
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients requiring renal replacement therapy.
- Use as a dual-lumen conduit to withdraw blood for dialysis and return filtered blood to the patient.
Clinical Applications
- Temporary central venous access for hemodialysis in patients with acute kidney injury.
- Hemodialysis access for patients with end-stage renal disease.
- Dialysis access while a more permanent option, such as an arteriovenous fistula or graft, is being created or matures.
- Use with standard hemodialysis equipment to support extracorporeal blood circulation.
Practical Considerations
- Available models include DE19/24SH, DE23/28SH, DE27/32SH, DE31/36SH, and DE19/24NH; the appropriate size depends on patient anatomy and the intended access site.
- Insertion is generally performed into a central vein using sterile technique and image guidance when appropriate. Common access regions include the internal jugular, femoral, and, less often, subclavian veins.
- The catheter must be connected to compatible dialysis tubing and equipment according to the manufacturer’s instructions.
- Potential complications include infection, bleeding, thrombosis, catheter malposition, inadequate blood flow, and central venous stenosis.
- MRI safety and conditions should be confirmed in the current device labeling before an MRI examination; do not assume that a catheter is MR safe or MR conditional.
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.