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Duet Long-Term Hemodialysis Catheter System Duet Long-Term Hemodialysis Catheter System Catheter Repair Kit
Summary: The Duet Long-Term Hemodialysis Catheter System is a medical device used for hemodialysis in patients requiring long-term vascular access. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090528 ↗
Decision Date ?
May 28, 2009
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Duet Long-Term Hemodialysis Catheter System was cleared via the FDA 510(k) pathway on May 28, 2009. Manufactured by C.R. Bard, it is a Class 2 device under product code MSD.
What It Is
The Duet Long-Term Hemodialysis Catheter System is designed to provide long-term vascular access for patients undergoing hemodialysis. It consists of a catheter that is inserted into a large vein, typically in the chest, to facilitate the removal and return of blood during dialysis sessions. The system includes a catheter repair kit to address potential issues without the need for complete device replacement.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients requiring dialysis treatment.
- Access through a large central vein for removing and returning blood during hemodialysis.
Clinical Applications
- Providing central venous access for repeated hemodialysis treatments.
- Use in patients who require long-term dialysis access.
- Hemodialysis access when an arteriovenous fistula or graft is not available or suitable, when consistent with the device labeling and clinical judgment.
- Repairing certain catheter defects with the catheter repair kit rather than replacing the complete catheter, when appropriate.
Practical Considerations
- The catheter is placed into a large central vein, commonly through the internal jugular vein, and is tunneled under the skin before exiting on the chest.
- Placement and management require sterile technique, imaging guidance when appropriate, and coordination with the dialysis team.
- The system is intended to connect with standard hemodialysis equipment; users should confirm catheter dimensions, connectors, flow requirements, and compatibility before use.
- Catheter size and length should be selected for the patient's anatomy and access site. The specific product labeling should be checked for available configurations.
- MRI safety depends on the exact catheter and repair-kit components. Confirm the current labeling and MR conditions before an MRI examination; do not assume the system is universally MRI safe.
Frequently Asked Questions
What is the Duet Long-Term Hemodialysis Catheter System used for?
It is used to provide long-term vascular access for patients undergoing regular hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device for patients requiring long-term hemodialysis.
What are the FDA-cleared indications?
The device is indicated for long-term vascular access in patients needing hemodialysis due to chronic kidney failure.
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.