DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)

DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS) is an FDA 510(k)-cleared medical device (K091760) manufactured by Dermaport, Inc.. 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 July 19, 2009. Regulation: 8.