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angiodynamics inc more-flow hemodialysis catheter and procedure kit
Angiodynamics
Summary: The More-Flow Hemodialysis Catheter by Angiodynamics is a medical device used for hemodialysis access. It is typically utilized by nephrologists and vascular surgeons to facilitate efficient blood flow during dialysis treatments.
FDA Clearance Information
Pathway 510K
Number K040402 ↗
Decision Date April 19, 2004
Product Code MSD
Device Class Class 2
Evidence 0 studies
The More-Flow Hemodialysis Catheter was cleared through the FDA 510(k) pathway on April 19, 2004. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code MSD.
What It Is
The More-Flow Hemodialysis Catheter is a specialized catheter designed for use in hemodialysis, a procedure to filter waste and water from the blood. It is inserted into a large vein, typically in the neck or chest, to provide reliable vascular access. The catheter's design ensures optimal blood flow rates necessary for effective dialysis sessions.
Clinical Applications
This catheter is commonly used in chronic kidney disease patients requiring long-term hemodialysis. Nephrologists and vascular surgeons typically place it in hospital or outpatient settings. It is crucial for patients who do not have a functioning arteriovenous fistula or graft, offering an alternative access point for dialysis.
Indications for Use
The FDA-cleared indications for the More-Flow Hemodialysis Catheter include providing vascular access for patients undergoing hemodialysis. It is intended for patients with end-stage renal disease who require regular dialysis treatments.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique is essential to minimize complications such as infection or thrombosis. Clinicians should be trained in catheter placement and maintenance.
Frequently Asked Questions
What is the More-Flow Hemodialysis Catheter used for?
It is used to provide vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis treatment settings.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for hemodialysis in patients with end-stage renal disease.
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.