(90 days)
The Adelante® Magnum is intended to facilitate the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements, while minimizing blood loss associated with such insertions. Do not use this device for neural placements.
Introducer, Model Adelante® Magnum
This document is a 510(k) clearance letter from the FDA for a medical device called "Introducer, model Adelante Magnum." It declares the device substantially equivalent to a predicate device. However, this document does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request for that specific information based solely on the provided text. The document primarily focuses on regulatory approval and substantial equivalence, not detailed performance studies.
§ 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).