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The Nexus I.V. Needless Access Cannula are intended for use to administer IV fluids / medication to the patients vascular system through a needle free system that aids in the prevention of necdle stick injuries.

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I am sorry, but the provided text does not contain any information regarding the acceptance criteria, device performance, or study details. The document is an FDA 510(k) clearance letter for an "I.V. Needless Access Cannula for Intravascular Administration," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• Trade/Device Name: I.V. Needless Access Cannula for Intravascular Administration
• Regulation Number: 21 CFR 880.5440
• Regulation Name: Intravascular Administration Set
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: To administer IV fluids/medication to the patients' vascular system through a needle-free system that aids in the prevention of needle stick injuries.
• 510(k) Number: K081123

However, it does not include any data from studies, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study details. This type of information is typically found in the 510(k) summary or in the full 510(k) submission, neither of which is provided here.

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