đź“‹ FDA Reference
15 5fr decathlon coated twin lumen chronic hemodialysis catheter with separated tips
Spire Biomedical
Summary: The 15 5fr Decathlon Coated Twin Lumen Catheter is a chronic hemodialysis catheter designed for vascular access in dialysis patients. It is used by nephrologists and interventional radiologists to facilitate long-term dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K060155 ↗
Decision Date
May 9, 2006
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 9, 2006. Manufactured by Spire Biomedical, it is classified as a Class 2 device under product code MSD.
What It Is
The 15 5fr Decathlon Coated Twin Lumen Catheter is a specialized medical device used for hemodialysis. It features a twin lumen design with separated tips, which helps to optimize blood flow and reduce recirculation during dialysis sessions. The catheter is coated to minimize thrombosis and infection risks, making it suitable for long-term use in patients requiring chronic dialysis.
Clinical Applications
This catheter is commonly used in nephrology and interventional radiology settings for patients with end-stage renal disease who require regular dialysis. It is typically inserted into central veins such as the internal jugular or subclavian vein. The device is particularly useful in patients who need reliable vascular access over extended periods, such as those awaiting kidney transplantation.
Indications for Use
The FDA indications for this device include providing vascular access for patients undergoing chronic hemodialysis. It is intended for use in patients who require long-term dialysis treatment due to kidney failure.
Practical Considerations
The catheter is typically available in various lengths to accommodate different patient anatomies. It is important to ensure proper placement and securement to minimize complications such as dislodgement or infection. Compatibility with dialysis machines and anticoagulation protocols should be considered during use.
Frequently Asked Questions
What is the 15 5fr Decathlon Coated Twin Lumen Catheter used for?
It is used for providing vascular access in patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists commonly use this device in dialysis settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring chronic 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.