(84 days)
The Low Profile Port system is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals, and the withdrawal of venous blood samples.
Low Profile Plastic Port Attachable Catheter with Blue Flex Tip® System / Introducer Kit
This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Low Profile Port® Attachable Catheter with Blue Flex Tip®/8Fr. Introducer Kit Implantable Vascular Access System."
Based on the provided text, there is no information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt. This document only states that the device has been found substantially equivalent to predicate devices and can now be marketed.
Therefore, I cannot populate the table or answer the other questions as the information is simply not present in the provided text.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).