(27 days)
The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.
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I am sorry, but the provided text focuses on the 510(k) summary for the X-Sept Transseptal Sheath and Transition Catheter, primarily detailing its substantial equivalence to a predicate device and its intended use. It does not contain information about specific acceptance criteria for a study, reported device performance metrics against such criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given input.
§ 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).