đź“‹ FDA Reference
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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 510K
Number K063431 ↗
Decision Date January 29, 2007
Product Code MSD
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.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease requiring regular hemodialysis. It is typically placed in hospital settings or outpatient dialysis centers by nephrologists or interventional radiologists. The device is suitable for both temporary and longer-term dialysis access, depending on the patient's vascular condition and treatment plan.
Indications for Use
The Decathlon Gold Hemodialysis Catheter is indicated for patients needing vascular access for hemodialysis. It is suitable for those with chronic kidney disease who require regular dialysis sessions.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and flow requirements. It is important to ensure proper placement and secure fixation to prevent dislodgement. Compatibility with dialysis machines and anticoagulation protocols should be verified before use.
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.