U.S. Filter receives FDA approval
United States Filter Corp. (Palm Desert, CA) has received Food and Drug Administration (FDA) 510(k) clearance for its complete water purification system used in hemodialysis. Considered a Class II medical device by the FDA, the system removes organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate. Water purified with the system can also be used for dialyzer reprocessing, equipment rinsing and disinfection. — TGW