INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) is an FDA 510(k)-cleared medical device (K992668) manufactured by Innerdyne, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2000. Regulation: 8.