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The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.

The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solution(s), through the openings located in the distal segment, into the selected coronary artery. The device has a single lumen shaft with a distally located inflation coil 20 mm, 30 mm or 50 mm in length. The number of coils increases with length. The inflation coil, encapsulated by a thin polyurethane sheath, may be inflated to further localize or isolate delivery to subselected vasculature. The lumen of the shaft is used to transport solutions, as well as to house an inner tube and inflation tube running the length of the shaft and situated concentrically within the lumen. The inner tube permits the use of coronary guide wires

This document describes a medical device, the SCIMED Dispatch Gold Coronary Infusion Catheter, and its comparison to existing predicate devices. It largely focuses on technical specifications and non-clinical testing to establish substantial equivalence.

Based on the provided text, I cannot extract the specific information requested in the prompt regarding acceptance criteria, study details, expert involvement, or ground truth for an AI device. The document pertains to a physical medical device, not an AI or algorithm-based system.

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