📋 FDA Reference
Duraflow 2 Chronic Hemodialysis Catheter and Procedure Kit
Product: DuraFlow — all models and sizes · Where to buy
Summary: The Duraflow 2 Chronic Hemodialysis Catheter is a medical device used for long-term hemodialysis access. It is typically used by nephrologists and vascular surgeons in patients requiring dialysis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K110936 ↗
Decision Date ?
June 10, 2011
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Duraflow 2 was cleared through the FDA 510k pathway on June 10, 2011. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code MSD.
What It Is
The Duraflow 2 Chronic Hemodialysis Catheter is designed to provide reliable vascular access for patients undergoing long-term hemodialysis. It is a tunneled catheter that is inserted into a central vein, typically the internal jugular vein, and is used to facilitate the removal and return of blood during dialysis. The device is engineered to minimize complications such as infection and thrombosis, offering a durable solution for patients with chronic kidney disease.
FDA-Cleared Indications
- Provide vascular access for hemodialysis.
- Use in patients requiring chronic or long-term hemodialysis access.
- Use when an arteriovenous fistula or graft is not available or is not suitable.
Clinical Applications
- Tunneled central venous access for long-term hemodialysis.
- Withdrawal of blood from the circulation for extracorporeal dialysis.
- Return of dialyzed blood to the circulation.
- Hemodialysis access in patients who cannot use or are awaiting creation of an arteriovenous fistula or graft.
Practical Considerations
- Placement is typically performed through a central vein, commonly the internal jugular vein, with imaging guidance and creation of a subcutaneous tunnel to the exit site.
- The catheter must be connected to compatible hemodialysis equipment and managed using strict sterile technique to reduce infection and malfunction.
- Available catheter configurations and sizes vary; clinicians select the appropriate option based on patient anatomy, access requirements and dialysis prescription.
- MRI safety depends on the specific catheter materials and labeling; the product-specific instructions for use should be reviewed before MRI.
- Potential complications include infection, thrombosis, catheter malfunction, bleeding, vessel injury, air embolism and central venous stenosis. Patient-specific contraindications and placement risks require clinical assessment.
Frequently Asked Questions
What is Duraflow 2 Chronic Hemodialysis Catheter used for?
It is used to provide long-term vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis units and outpatient centers.
What are the FDA-cleared indications?
The device is indicated for providing vascular access for hemodialysis in patients with chronic kidney disease who need long-term dialysis access.
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.