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retro silver and xpresso silver chronic hemodialysis catheters
Spire Biomedical
Summary: The Retro Silver and Xpresso Silver are chronic hemodialysis catheters used for vascular access in patients requiring long-term dialysis. They are typically used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K060288 ↗
Decision Date
September 1, 2006
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Retro Silver and Xpresso Silver catheters were cleared via the FDA 510(k) pathway on September 1, 2006. Manufactured by Spire Biomedical, these devices are classified as Class 2 under product code MSD.
What It Is
The Retro Silver and Xpresso Silver catheters are specialized medical devices designed for chronic hemodialysis. They function as vascular access tools, allowing repeated access to the bloodstream for dialysis treatment. These catheters are typically inserted into large veins, such as the internal jugular or subclavian vein, and are designed to remain in place for extended periods, facilitating ongoing dialysis sessions.
Clinical Applications
These catheters are commonly used in patients with end-stage renal disease who require long-term dialysis. They are typically placed in hospital settings or outpatient dialysis centers by nephrologists or vascular surgeons. The catheters are suitable for patients who do not have a suitable arteriovenous fistula or graft, providing an alternative access point for hemodialysis.
Indications for Use
The FDA indications for these catheters include use in patients who need chronic hemodialysis. They are intended for individuals who require reliable and long-term vascular access for dialysis treatments.
Practical Considerations
These catheters come in various sizes to accommodate different patient anatomies and are compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis. Regular monitoring and maintenance are essential to ensure catheter patency and function.
Frequently Asked Questions
What is Retro Silver and Xpresso Silver used for?
These catheters are used for providing vascular access in patients requiring chronic hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use these catheters in dialysis settings.
What are the FDA-cleared indications?
The catheters are indicated for use in patients needing long-term vascular access for 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.