📋 FDA Reference
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 ?
510(k)
Number ?
K060288 ↗
Decision Date ?
September 1, 2006
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for patients requiring chronic hemodialysis.
- Long-term access to the bloodstream for hemodialysis treatments.
Clinical Applications
- Providing central venous access for repeated chronic hemodialysis.
- Dialysis access when an arteriovenous fistula or graft is not suitable or available.
- Use in patients requiring ongoing hemodialysis through an implanted or tunneled catheter.
Practical Considerations
- Catheter size and configuration should be selected for the patient's anatomy, blood-flow requirements and dialysis system.
- Placement is generally performed using image guidance, often through the internal jugular vein; subclavian access may also be considered depending on the clinical situation.
- The catheter must be handled with sterile technique and monitored for infection, thrombosis, malfunction and poor blood flow.
- Confirm MRI compatibility and any conditions for scanning in the current manufacturer instructions before an MRI examination.
- Potential contraindications and precautions include infection at the insertion site, unsuitable venous anatomy, thrombosis and inability to maintain catheter care.
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.