Search Results

intended for channeling blood during Haemodialysis Treatement.

Not Found

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Cuprophan which is substantially equivalence to the Cuprophan membranes utilized in the cobe centry System 160E and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dialyzers are manufactured by Akzo (Enka) of Germany. Cuprophan membrane is also utilized in Baxter CF25 Dialyzers. Hemophan membrane is also manufactured by Akzo (Enka) and is also cellulose membrane but derivative from Cuprophan membrane. Blood enters a blood inlet port where it is distributed to Cuprophan and Hemophan membrane. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns. Blood is bumped via a roller pump from the artery of the patient into the arterial end of the dialvzer. The blood travels down through the dialyzer fibers where waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dilayzer on the outside of the hollow fibers. Blood then exits the venous end of the dilayzer back to the patient.