PATHWAY ACCESS SHEATH CATHETER

PATHWAY ACCESS SHEATH CATHETER is an FDA 510(k)-cleared medical device (K030662) manufactured by Vertelink Corporation. 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 September 2, 2003. Regulation: 8.