NXSTAGE PUREFLOW-B SOLUTION

NXSTAGE PUREFLOW-B SOLUTION is an FDA 510(k)-cleared medical device (K042045) manufactured by Nxstage Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2004. Regulation: 8.