đź“‹ FDA Reference
15 5 Fr Decathlon Gold Funnel TIPS Coated Hemodialysis Catheter DFC19SH24 DFC23SH28 DFC27SH32 DFC31SH36 DFC35SH40
Spire Biomedical
Summary: The Decathlon Gold Hemodialysis Catheter is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K063431 ↗
Decision Date ?
January 29, 2007
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Decathlon Gold Hemodialysis Catheter was cleared via the FDA 510k pathway on January 29, 2007. Manufactured by Spire Biomedical, it is classified as a Class 2 device.
What It Is
The Decathlon Gold Hemodialysis Catheter is a dual-lumen catheter designed for use in hemodialysis. It features a gold-coated funnel tip to enhance flow dynamics and reduce clot formation. The catheter is inserted into a central vein, typically the jugular or femoral vein, to provide reliable vascular access for dialysis treatments.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients who require dialysis treatment.
- Placement in a central vein to allow blood withdrawal and return during hemodialysis.
Clinical Applications
- Providing temporary or longer-term central venous access for hemodialysis, according to the labeling and clinical treatment plan.
- Hemodialysis access through a central vein such as the internal jugular or femoral vein when clinically appropriate.
- Use in patients with kidney failure or advanced chronic kidney disease who require hemodialysis.
Practical Considerations
- The listed devices are 15 French catheters with model-specific lengths: DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, and DFC35SH40.
- The catheter must be placed and secured using sterile technique, with imaging guidance and confirmation of the catheter tip location according to institutional practice.
- Before use, confirm compatibility with the dialysis machine, bloodlines, connectors, flushing solutions, and anticoagulation protocol.
- MRI safety depends on the exact catheter configuration and labeling. The device should be treated as MRI-conditional or unevaluated until the current manufacturer instructions confirm MRI conditions.
- Important risks include infection, bleeding, thrombosis, vessel injury, malposition, air embolism, catheter dysfunction, and central venous stenosis. Patient-specific contraindications and access-site limitations should be assessed before placement.
Frequently Asked Questions
What is the Decathlon Gold Hemodialysis Catheter used for?
It is used for providing vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for use in patients requiring vascular access for hemodialysis.
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.