(70 days)
The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.
The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.
This document is a 510(k) premarket notification for the Cordis Endeavor Infusion Catheter and does not contain the specific information requested in the prompt. The document describes an administrative change to a previous substantial equivalence determination letter and discusses the general regulatory requirements for the device. It provides a summary of safety and effectiveness but does not include details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of a device based on AI/ML.
Therefore, I cannot extract the requested information from this document.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).