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55cm 15 5fr decathlon twin lumen hemodialysis catheter w separated tips
Spire Biomedical
Summary: The 55cm 15 5fr Decathlon Twin Lumen Hemodialysis Catheter by Spire Biomedical is a device used for hemodialysis in patients requiring vascular access. It is typically used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K042858 ↗
Decision Date
December 3, 2004
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 3, 2004, by Spire Biomedical. It is classified as a Class 2 medical device under product code MSD.
What It Is
This is a twin lumen hemodialysis catheter designed for vascular access in patients undergoing hemodialysis. The catheter features separated tips to improve flow dynamics and reduce recirculation during dialysis. It is typically inserted into a central vein, such as the internal jugular or femoral vein, to facilitate efficient blood exchange during treatment.
Clinical Applications
Commonly used in hospital settings, this catheter is essential for patients with chronic kidney disease requiring regular hemodialysis. Nephrologists and interventional radiologists often place these catheters in patients who need immediate dialysis access or when long-term arteriovenous fistulas are not yet available. It is also used in acute settings for patients with sudden kidney failure.
Indications for Use
The catheter is indicated for patients needing vascular access for hemodialysis, particularly those with end-stage renal disease or acute kidney injury. It is suitable for both temporary and semi-permanent access needs.
Practical Considerations
The 55cm length and 5 French size make it suitable for adult patients, providing a balance between ease of insertion and adequate flow rates. Clinicians should ensure compatibility with dialysis machines and consider patient-specific anatomical factors during placement.
Frequently Asked Questions
What is the 55cm 15 5fr Decathlon Twin Lumen Hemodialysis Catheter used for?
It is used for providing vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrology and interventional radiology specialties typically use this device.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring hemodialysis, such as those with end-stage renal disease or acute kidney injury.
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.