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The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.

The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.

Components will be assembled into standard configurations specified by the customer and packaged.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, clinical study design, or expert involvement as described in your request. The document appears to be a 510(k) summary for an "Intravascular Administration Set and Extension Set," primarily focusing on regulatory information, device description, intended use, and biocompatibility, but not on clinical performance evaluation details.

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