Search Results

The Talon insulin pump infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump

The Talon infusion sets are connected to a medication reservoir proximally (i.e., a syringe that is placed within an infusion pump, such as an insulin pump) and distally inserted into the subcutaneous tissue of the user. The infusion set attaches to the medication reservoir by means of a female luer connector and is inserted into the patient through an introduction cannula. The 26 gauge indwelling catheter is connected to tubing of various lengths. The materials used for the components include: PVC/polyethylene; polyvinyl chloride; polytetrafluorethylene; stainless steel; polycarbonate; polypropylene; and, trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria for the Talon Infusion Set. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study data.

Therefore, I cannot complete the table or answer the questions based on the provided input. The document primarily describes the device, its intended use, and confirms its 510(k) clearance by the FDA.

Ask a specific question about this device