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The 6F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

The Cordis 6F Hydrolyser Thrombectomy Catheter system consists of a 6F Catheter and an Accessory Kit. The 6F Catheter is a 65 cm triple lumen catheter which consists of an injection lumen that allows for saline to be injected, an exhaust lumen that allows for the fluid to be transported into a collection bag and a guidewire lumen.

The provided documents are FDA letters regarding the 510(k) clearance of the Cordis 6F Hydrolyser Thrombectomy Catheter. These documents do not describe acceptance criteria, performance data, or detailed study information in the format requested.

The documents confirm that the device was deemed "substantially equivalent" to a predicate device (Cordis 7F Hydrolyser Thrombectomy Catheter) based on "pre-clinical and clinical testing." However, the details of these tests, including specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not provided in these summaries.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or elaborate on the study details. The information necessary to answer those specific points is not present in the provided text.

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