MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER

MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER is an FDA 510(k)-cleared medical device (K933020) 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 January 2, 1994. Regulation: 8.