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The AngioDynamics, Inc. More-Flow™114 Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative inscrtion sites include the subclavian vein as required. Catheters greater than 40cm are intended for femoral vein insertion.

AngioDynamics, Inc. More-Flow™ Hemodialysis Catheter and Procedure Kit

The provided document is a 510(k) clearance letter from the FDA for a medical device: "AngioDynamics, Inc. More-Flow™ Hemodialysis Catheter and Procedure Kit." This type of document establishes substantial equivalence to a predicate device, allowing the manufacturer to market it.

This document does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

The 510(k) clearance process primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically include the detailed performance study results that would satisfy the criteria you've outlined for an AI/ML device or a novel medical device requiring extensive clinical trials to establish efficacy and safety.

Therefore, I cannot fulfill your request using the provided text.

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