VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES is an FDA 510(k)-cleared medical device (K853101) manufactured by Cobe Laboratories, 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 February 23, 1986. Regulation: 8.