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duraflow 2 chronic hemodialysis catheter and procedure kit
Angiodynamics
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
510K
Number
K110936 ↗
Decision Date
June 10, 2011
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in nephrology and vascular surgery settings, particularly in hospital dialysis units and outpatient dialysis centers. It is suitable for patients who require long-term hemodialysis but do not have a functioning arteriovenous fistula or graft. The device is also used in patients with acute kidney injury who need temporary dialysis access while awaiting more permanent solutions.
Indications for Use
The FDA indications for the Duraflow 2 include providing vascular access for hemodialysis in patients with chronic kidney disease. It is intended for use in patients who require long-term dialysis access and are not candidates for arteriovenous fistula or graft placement.
Practical Considerations
The Duraflow 2 is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis equipment and requires careful insertion technique to avoid complications. Clinicians should be trained in catheter placement and maintenance to ensure optimal outcomes.
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.