(166 days)
The intended use is to facilitate the placement of other devices such as guidewires, central venous catheters, peripherally inserted central venous catheters, and probes in the vascular system.
The subject catheter is a short term, single use introducer catheter of various gauges and lengths which is designed to split and peel away following use. It is inserted into the vascular system over a needle.
This document (K954906) is a 510(k) premarket notification for an introducer catheter. It outlines the device description, intended use, and comparison to predicate devices for demonstrating substantial equivalence. It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or AI-related aspects.
Therefore, I cannot provide the requested information as it is 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).