Search Results

Ask a specific question about this device

THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".

Not Found

This document is a marketing clearance letter from the FDA for a medical device, the "Exel Injection Plug W/Cap." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

The document does NOT contain information about acceptance criteria, study details, or device performance metrics for the Exel Injection Plug W/Cap.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study.

Ask a specific question about this device