Search Results

X-Coated CAPIOX® SX25 and SX18 Hollow Fiber Oxygenators The with/without Detachable Hardshell Reservoirs are used to exchange gases with without and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours.

The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device.

(detachable) hardshell reservoir is used to store blood during The extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.

The X-Coat is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.

X-Coated CAPIOX® SX25 and SX18 Hollow Fiber Oxygenators with/without Detachable Hardshell Reservoirs. The device is used to exchange gases with a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. It includes an integral heat exchanger to warm or cool blood or perfusion fluid. The detachable hardshell reservoir stores blood and contains filters and defoamers to remove air bubbles and particulate matter. The device has an X-Coat polymer coating on blood contacting surfaces to reduce platelet adhesion.

The provided text is a summary of generic safety and effectiveness issues for oxygenators and defoamers, likely from a regulatory submission (indicated by "K993772"). It does not describe an acceptance criteria for a specific device, nor does it contain a study proving a device meets acceptance criteria.

Therefore, I cannot extract the requested information. The document lists potential causes for various problems related to these devices, drawing from medical databases and literature, but it does not present a structured study with defined acceptance criteria and performance data for a particular device.

To fulfill your request, I would need a document that presents:

1. Specific, quantifiable acceptance criteria for a particular oxygenator or defoamer.
2. Performance data from a study designed to evaluate that device against those criteria.

Ask a specific question about this device