(89 days)
The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.
The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.
This document is a 510(k) summary for the MicroCruiser® Plus Introducer Set. It outlines the device description, indications for use, and a comparison to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information based on this document. The provided text is a regulatory submission for device clearance, not a study report detailing performance metrics and validation.
§ 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).