DURASPAN HEMODIALYSIS LONG-TERM CATHETER

DURASPAN HEMODIALYSIS LONG-TERM CATHETER is an FDA 510(k)-cleared medical device (K100169) manufactured by R4 Vascular, 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 February 17, 2010. Regulation: 8.