VAXCEL DIALYSIS CATHETER

VAXCEL DIALYSIS CATHETER is an FDA 510(k)-cleared medical device (K012365) manufactured by Boston Scientific Corp. 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 23, 2001. Regulation: 8.