14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)

14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) is an FDA 510(k)-cleared medical device (K062671) manufactured by Kendall. 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 2, 2006. Regulation: 8.