RIVER EDGE, N.J., Nov. 10, 2011 /PRNewswire/ -- Nephros, Inc. (OTC Bulletin Board: NEPH) announced that it has received the initial review by the Food and Drug Administration ("FDA") of the 510(k) application for marketing clearance of the company's hemodiafiltration system.
On August 11, 2011 Nephros submitted a new 510(k) application to market its hemodiafiltration (HDF) system for end-stage renal disease. On November 8, 2011 Nephros received the initial FDA review of its new 510(k) application (K112314), which included a request for additional information.
As the next step, Nephros will respond to the FDA's request for more information. Nephros intends to provide its response within 30 days or request an extension of time to respond, if necessary.
The application details Nephros's OLpur MD220 hemodiafilter and Nephros's OLpur H2H Hemodiafiltration module. Nephros's OLpur MD220 is a dialyzer designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution hemodiafiltration technology. Nephros's OLpur H2H Hemodiafiltration module is designed to enable the most common types of standard dialysis machines to perform HDF therapy. Nephros believes that, if cleared, its technology would be the first approved on-line HDF therapy available in the U.S.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of har
|SOURCE Nephros, Inc.|
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