SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. is an FDA 510(k)-cleared medical device (K901624) manufactured by Shiley, 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 July 2, 1990. Regulation: 8.