(339 days)
The Adelante® Radial Introducer Set is indicated for the introduction of diagnostic and therapeutic catheters into the human vasculature. Do not use this device for neural placements.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Adelante® Radial Introducer Set." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The letter approves the device based on its substantial equivalence to predicate devices already on the market but does not detail the specific performance metrics or studies that established this equivalence. It's a regulatory approval, not a technical performance report.
Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory communication.
§ 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).