(234 days)
The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.
Medcomp Tri-Flow™ Soft Tip Triple Lumen Catheters
I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer regarding a 510(k) premarket notification. It states that the device, Medcomp Tri-Flow™ Triple Lumen Catheter, has been determined to be substantially equivalent to previously marketed devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request based on the provided input.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).