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The Y Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 (FR 801.109(b)(1))

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the V Set device. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It defines the device, its intended use, and regulatory information, but does not include any performance data or study details.

Therefore, I cannot provide the requested information in the specified format.

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The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance, or any of the other specific details requested in your prompt.

The document is a letter from the FDA to Henning Enterprises Europe S.R.L. regarding their "V Set" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes an "Indications for Use Statement" for the V Set.

This type of document typically confirms regulatory clearance but does not contain detailed study results, acceptance criteria, or performance metrics.

Ask a specific question about this device