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The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F Catheter and an Accessory Kit.

The 7F Catheter is a 65 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.

This is a 510(k) premarket notification for the Cordis 7F Hydrolyser Thrombectomy Catheter, which received substantial equivalence on February 26, 1999. The device is indicated for the percutaneous removal of soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.

While the document confirms the device's substantial equivalence to predicate devices and mentions "pre-clinical and clinical testing" to confirm this equivalence, it does not provide detailed acceptance criteria or the specific results of those studies. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, ground truth establishment, or specific study designs (MRMC, standalone).

The document is a regulatory approval letter and a summary of safety and effectiveness, which typically provides high-level information rather than detailed study protocols and results.

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