MODIFICATION TO VAXCEL DIALYSIS CATHETER

MODIFICATION TO VAXCEL DIALYSIS CATHETER is an FDA 510(k)-cleared medical device (K012948) manufactured by Boston Scientific/Medi-Tech. 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 October 2, 2001. Regulation: 8.