INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM

INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K972684) 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 October 9, 1997. Regulation: 8.