NAVIGATOR URETERAL ACCESS SHEATH SET

NAVIGATOR URETERAL ACCESS SHEATH SET is an FDA 510(k)-cleared medical device (K030956) 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 May 22, 2003. Regulation: 8.