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The Haemonetics 40μ RBC Filter Bag is intended for use for perioperative autologous transfusion to hold washed red blood cells from a Haemonetics cell salvage device and filter the RBCs for microaggregates greater than 40 microns. It is intended to eliminate the need for a discrete 40 micron filter often used to filter autotransfusion blood prior to reinfusion.

The Haemonetics 40µ RBC Filter Bag is described as a blood transfusion microfilter with FDA Product Code CAK in the FDA Guidance Document for Intravascular Administration Sets 510(k)s dated April 15, 2005. It is defined as a Class II medical device in 21 CFR 880.5440 and is included as a component for an Intravascular Administration Set.

The Summit Medical Transfusion Filter is intended for the filtration of up to one unit of intra-operative or post-operative salvaged blood, for the reduction of lipid particles, anaphylatoxin C3a, microaggregates and leucocytes. It is indicated for the reinfusion of blood derived from the surgical site or post-operative wound drainage.

The Transfusion Filter device consists of a sterile, single wrapped package, containing a filter assembly, with or without an administration set. The administration set is fitted with a drip chamber and roller clamp. The filter unit is connected to a flexible bag containing the blood to be reinfused via a spike port in the bag. The filter is primed by holding the bag inverted, with the filter above the bag, then squeezing the bag to force blood through the filter medium and to the desired level within the drip chamber. The roller clamp is then closed, and the system hung on a drip stand ready for use. The administration line can then be primed and connected to the patient according to clinical practice, and the rate of blood flow to the patient requlated by adjusting the roller clamp.

Single use device for the removal of microaggregate and particulate debris from whole blood and red blood cells (RBCs) during infusion.

40 micron filter offered both as a stand alone device and as an integral component of a Y-Blood Administration Set.

The Fenwal® 20 Micron Pediatric Transfusion Filter is indicated for the removal of microaggregate particles from whole blood and red blood cells.

Baxter's Fenwal® 20 Micron Pediatric Transfusion Filter is a depth-type filter which traps microaggregates composed of degenerating platelets, leukocytes, fibrin strands and other particles which form in blood after storage. The filter consists of a fiber pad supported by a screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. The filter pad is currently comprised of five types of fiber strands. The supplier of one of the fibers has discontinued production. We are proposing to eliminate two of the five fibers used in construction of the filter pad and increase the percentage composition of the remaining three sizes. This change will make the composition of the 20 micron pediatric filter pad identical to the composition of the pad in the Fenwal® 20 Micron High Capacity Transfusion Filter covered by K830057.

The 40 Micron Transfusion Filter is indicated for removal of microaggregate particles from whole blood and red blood cells and for transfusion of platelets.

Baxter is currently marketing a 40 Micron Transfusion Filter indicated for the removal of microaggregates from whole blood and red blood cells and for the transfusion of platelets. The filter consists of a fiber pad supported by a single layer screen contained in a housing. The subject of this submission is a change in the fiber composition of the filter pad. Fibers which comprise approximately 50% of the current filter pad are being discontinued by the supplier. These fibers are being replaced with fibers from another supplier which differ in size and material formulation.

The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

The Alpha Micron®-20/40 Microaggregate Filter is a filter used for the filtration of microaggregate debris from plasma derivative products in order to aid in the prevention of pulmonary embolization. The device is designed to be utilized in either of two applications; by syringe, or by administration set. The syringe is inserted into the exposed inlet of the filter while the spike end is inserted into the bottle (or bag) of the plasma derivative. The blood plasma derivative is aspirated through the filter into the syringe resulting in filtration. The administration set is placed into the exposed inlet of the filter while the spike end is attached to an infusion set. The plasma derivative is drawn through the filter during administration resulting in filtration.