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The DYNAMIC Hollow Fiber Dialyzer DH-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. 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.

Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Focus R-Series Hollow Fiber Dialyzers (K914790) and Gambro GFS plus Series Hemodialyzer (K902481), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Focus R-Series Hollow Fiber Dialyzers and the proposed device is 8 microns. The inner diameter of hollow fibers in both Focus R-Series Hollow Fiber Dialyzers, Gambro GFS plus Series Hemodialyzer and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

The DYNAMIC Hollow Fiber Dialyzer DS-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. 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.

Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 40 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, and the proposed device is 40 microns. The inner diameter of hollow fibers in predicate devices and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.

The DYNAMIC Hollow Fiber Dialyzer DC-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. 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 membrane used in this device which is substantially equivalent to the membranes utilized in the Cobe CentrySystem 160E and Baxter CF25 Dialyzers, which have been previously approved under a 510(k) Notification (K8G4831). Blood enters a blood inlet port where it is distributed to hollow fibers. 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 equivalent in design to the previously approved Cobe CentrySystem 160E Dialyzers. The wall thickness of the hollow fibers in Cobe CentrySystem 160)E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameller of hollow fibers in both Baxter CF25 Dialyzers and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.