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AngioDynamics Inc More-Flow Hemodialysis Catheter and Procedure Kit
Product: EvenMore — all models and sizes
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 ?
510(k)
Number ?
K040402 ↗
Decision Date ?
April 19, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Providing vascular access for hemodialysis.
- Use in patients who require hemodialysis and need catheter-based central venous access.
Clinical Applications
- Catheter-based vascular access for hemodialysis treatments.
- Hemodialysis access when an arteriovenous fistula or graft is not available or cannot be used.
- Placement through a central vein, such as the internal jugular or subclavian vein, for dialysis blood flow.
- Use with compatible standard hemodialysis equipment according to the device labeling and instructions for use.
Practical Considerations
- The catheter is placed using sterile technique, typically with ultrasound and fluoroscopic or other imaging guidance, depending on the access site and clinical setting.
- Available catheter sizes and configurations should be selected for the patient's anatomy, prescribed blood-flow requirements and dialysis equipment.
- Potential complications include infection, bleeding, venous thrombosis, catheter malfunction, air embolism, vessel injury and abnormal heart rhythm during placement.
- The product labeling and manufacturer instructions should be checked for MRI conditions, including whether the specific catheter configuration is MR Safe, MR Conditional or not evaluated for MRI.
- Catheter placement or use may be unsuitable in patients with infection at the planned access site, severe coagulopathy, central venous occlusion or other contraindications identified by the treating clinician.
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.