(140 days)
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.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).