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An intravascular administration set intended to administer fluids from a fluid container (I.V. bag) to a patient's vascular system through a needle or catheter inserted into a vein.

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I'm sorry, but this document contains a medical device approval letter from the FDA, and it does not include the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. This letter is a regulatory document stating that the device, "SelectFlow Intravascular Administration Set," has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary with performance data. This document primarily focuses on the regulatory approval status.

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