đź“‹ FDA Reference
decathlon gold twin lumen hemodialysis catheter with separated tips models dec19sh24 dec23sh28 dec23sh32 dec31sh36
Spire Biomedical
Summary: The Decathlon Gold Twin Lumen Hemodialysis Catheter is a medical device used for hemodialysis, primarily by nephrologists and dialysis specialists. It facilitates efficient blood flow for dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K073093 ↗
Decision Date
January 22, 2008
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Decathlon Gold Twin Lumen Hemodialysis Catheter was cleared via the FDA 510(k) pathway on January 22, 2008. It is manufactured by Spire Biomedical and is classified as a Class 2 device.
What It Is
The Decathlon Gold Twin Lumen Hemodialysis Catheter is a specialized catheter designed for hemodialysis, featuring twin lumens with separated tips to optimize blood flow and reduce recirculation. It is inserted into a large vein, typically in the neck, chest, or groin, and allows for the removal and return of blood during dialysis. The catheter's design aims to improve dialysis efficiency and patient outcomes.
Clinical Applications
This catheter is commonly used in patients requiring temporary or semi-permanent vascular access for hemodialysis. It is typically utilized in hospital settings, dialysis centers, and sometimes in home dialysis setups. Nephrologists and interventional radiologists are the primary specialists involved in its placement and management, often dealing with patients who have chronic kidney disease or acute kidney injury.
Indications for Use
The catheter is indicated for use in patients who need hemodialysis, particularly those who require reliable vascular access. It is suitable for individuals with kidney failure who need regular dialysis treatments.
Practical Considerations
The catheter comes in various sizes, such as 19cm, 23cm, and 31cm, allowing for flexibility based on patient anatomy and the site of insertion. 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 Gold 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 commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring hemodialysis, providing reliable vascular access for dialysis treatments.
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.