Search Results

An intravascular catheter, inserted peripherally for long-term All intravasoalar outhors for parenteral nutrition and/or administration of drugs

Not Found

This is an FDA 510(k) clearance letter for the Vygon Nutriline Catheters, dated August 19, 2005. This document indicates the device has been found substantially equivalent to predicate devices already on the market.

It is important to note that 510(k) clearance letters typically do not contain detailed information about specific acceptance criteria or the studies used to prove those criteria were met. Instead, they confirm that the FDA has reviewed the submission and found the new device to be as safe and effective as a legally marketed predicate device. The information you are requesting is usually found in the original 510(k) submission, which is not provided in this document.

Therefore,Based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This document is a regulatory clearance letter, not a scientific study report.

Ask a specific question about this device