(186 days)
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.
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
Identification. A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”