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The Pall STAT-PRIMe Blood Filter for Extracorporcal Service is indicated for use in cardiopulmonary bypass procedures for the removal of microemboli in the arterial return line.

Pall Stat-Prime D Blood Filter for Extracorporeal Service (Featuring the Duroflo® Treatment)

This is a 510(k) premarket notification document for the Pall Stat-Prime D Blood Filter for Extracorporeal Service, indicating FDA clearance. The document itself does not contain a detailed study description with acceptance criteria and device performance results. Instead, it states the "Indications For Use" for the device, which is for the removal of microemboli in the arterial return line during cardiopulmonary bypass procedures.

Therefore, I cannot provide the requested information based on the provided text, as it does not contain the specific study details. This document primarily serves as an FDA clearance letter based on substantial equivalence to a predicate device, rather than a detailed report of a clinical or performance study.

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