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15 5fr alta gold coated hemodialysis catheter model alc19sh24 alc23sh28 alc27sh32 alc31sh36 alc35sh40 alc50sh55
Spire Biomedical
Summary: The 15 5fr Alta Gold Coated Hemodialysis Catheter by Spire Biomedical is a device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K063441 ↗
Decision Date
February 12, 2007
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 12, 2007. It is manufactured by Spire Biomedical and is classified as a Class 2 device under product code MSD.
What It Is
The 15 5fr Alta Gold Coated Hemodialysis Catheter is a specialized catheter designed for use in hemodialysis. It features a gold coating, which may help reduce thrombogenicity and infection risk. The catheter is inserted into a large vein, typically in the neck or groin, to provide access to the bloodstream for dialysis treatment.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease requiring hemodialysis. It is typically employed in hospital settings, dialysis centers, or outpatient clinics. Nephrologists and vascular surgeons are the primary specialists who use this device, often in patients who need temporary or semi-permanent vascular access.
Indications for Use
The catheter is indicated for patients who require vascular access for hemodialysis. It is suitable for those with end-stage renal disease or acute kidney injury needing dialysis.
Practical Considerations
The catheter comes in various sizes, allowing for flexibility depending on patient anatomy and clinical needs. It is important to ensure compatibility with dialysis machines and to follow aseptic technique during insertion to minimize infection risk.
Frequently Asked Questions
What is the 15 5fr Alta Gold Coated 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 vascular surgeons typically use this device in dialysis settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients requiring 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.