Navigation Links
Nephros Receives Initial FDA Response to 510(k) Application for Hemodiafiltration System
Date:11/10/2011

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.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
2. Nephros Reports 2009 Third Quarter Financial Results
3. Nephros Signs Canadian Distribution Agreement with Bellco Health Care Inc.
4. Nephros Signs Development Agreement with STERIS
5. Nephros Reports 2010 First Quarter Financial Results
6. Nephros and AmeriWater Announce Dual Stage Ultrafilters to be a Standard Component of MRO Series Water Treatment Systems
7. Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System
8. Nephros Reports 2010 Second Quarter Financial Results
9. Nephros Completes Bridge Financing and Announces Stockholder Rights Offering
10. Nephros Reports 2010 Third Quarter Financial Results
11. Nephros Rights Offering Registration Statement Declared Effective
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... , Dec. 19, 2014  In the Friday, December 19 edition ... supplement dedicated to Healthcare Information Technology (HIT) features Konica Minolta, the ... IT in partnership with several leading healthcare organizations. ... several major metropolitan markets, such as New York ... / Baltimore , Minneapolis and ...
(Date:12/19/2014)... TODAY, AEGATE, the leader in ... the appointment of Peter Fox as Chief ... and Partner Officer. Peter has served as ... acquisition by Oracle in 2011. Prior to ... and subsequently Convergys, a world renowned billing ...
(Date:12/19/2014)... , Dec. 19, 2014  Newport Corporation (NASDAQ: ... Kadia, Ph.D. has joined the company,s Board of ... Officer and a director of Evans Analytical Group, ... evaluation and analytical services to companies in a ... to joining Evans Analytical Group, Dr. Kadia spent ...
Breaking Medicine Technology:USA Today Supplement Featuring Konica Minolta Focuses on Impact of Healthcare IT 2Aegate Appoints new CTO and Chief Channels & Partner Officer 2Aegate Appoints new CTO and Chief Channels & Partner Officer 3Aegate Appoints new CTO and Chief Channels & Partner Officer 4Siddhartha Kadia, Ph.D. Joins Board of Directors of Newport Corporation 2
(Date:12/20/2014)... (PRWEB) December 20, 2014 Dress company LunaDress ... dresses, and announced its Christmas Sale, offering big discounts on ... “Every girl has an idea to own a perfect wedding ... for your wedding dress, then come to LunaDress. Many different ... for you. Visit our website now and enjoy the current ...
(Date:12/20/2014)... News) -- The holidays can be anything but joyous ... trees, scented candles and other allergy triggers. "The ... have been packed away in dank basements or dusty ... patients," Dr. Rachna Shah, an affiliate faculty member at ... Loyola news release. Shah, who is also an ...
(Date:12/20/2014)... the distinguished wedding dress manufacturer and retailer, has just ... has recently updated its official blog with the latest ... Angeldress Blog has recommended some new designs and ... in offering a huge selection of elegant products and ... are very carefully selected based on the design and ...
(Date:12/20/2014)... New York, NY (PRWEB) December 20, 2014 ... Entertainment has caused quite a stir, not only in Hollywood, ... Times on December 18th , the ripples of that attack ... level executives’ very jobs at risk. But they are ... email correspondences exposed could be in for some embarrassing times ...
(Date:12/20/2014)... (PRWEB) December 20, 2014 Xarelto ... they suffered uncontrollable bleeding and other serious side ... Eastern District of Louisiana for coordinated pretrial proceedings, Wright ... Multidistrict Litigation (JPML) issued an order Friday to transfer ... pending in 22 federal courts to the Louisiana district ...
Breaking Medicine News(10 mins):Health News:2015 Collection of Wedding Dresses from LunaDress Online on Sale Now 2Health News:Holiday Trimmings Can Trigger Allergies 2Health News:Trendy Professional Wedding Apparel Recommended by Angeldress Blog 2Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 2Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 3Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 4Health News:Sony Pictures Hack Perfect Example of the Reach a Single Cyber Attack Can Have 5Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 2Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 3Health News:Xarelto Bleeding Lawsuits Consolidated To Louisiana Federal Court For Multi-District Litigation Reports Wright & Schulte LLC 4
... protein that lets mice eat more but weigh less could ... scientists from drug giant SmithKline Beecham and the University of ... Uncoupling Protein 3 (UCP3) that increases their metabolism.In what is ... than normal mice but still weigh less. , , ,"Extra ...
... the gene associated with the inherited form of primary pulmonary ... and James A. Knowles of the Columbia Genome Center is ... part by the National Heart, Lung, and Blood Institute at ... issue of the American Journal of Human Genetics, provides new ...
... concern over the AIDS crisis ravaging sub-Saharan Africa dominates much ... Conference, researchers and AIDS workers are sounding the alarm for ... have a very serious catastrophe in the offing, and if ... China, and it's not any of the other superpowers--the big ...
... low levels that are making news. Recent reports are ... and violent behavior. A new study shows that men with ... likely to report symptoms of severe depression. Edward Suarez, ... Said, "I think that at some point, measurement of ...
... they are told to consider a hysterectomy because they ... very rare that a fibroid tumor could become cancerous,' ... the Stanford University School of Medicine.,Fibroids are benign growths ... bleeding. ,According to Dr. Kevin Reynolds, chief of gynecologic ...
... to all of you who thought that one only uses ... have come out in the recent years which are dermatocentric ... which was devised for liver transplantation, there has been found ... disease because of its chronicity as well as the symptomatology ...
Cached Medicine News:
Its generous filter placement, MicroPoint design, and reference marks at 10, 50, and 100 ul make this ART tip ideal for many 200 ul pipettors....
... tips, microfuge tubes and PCR tubes. ... RNase- and DNase-free. Tubes have a ... 120°C. Available in a variety of ... a low binding surface. PCR Tubes ...
Designed for the Eppendorf and Pipetman 100 ul pipettors, this tip features MicroPoint design, reference mark at 10 ul and a yellow tip design for the most universal fit....
Diamond Filter Tips play a critical role in preventing aerosol-borne contamination. Also available sterilized (no need to autoclave) and certified free of detectable RNase, DNase, DNA, RNA, and prote...
Medicine Products: