ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER is an FDA 510(k)-cleared medical device (K102043) manufactured by Rex Medical. 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 November 17, 2010. Regulation: 8.