VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING is an FDA 510(k)-cleared medical device (K023381) manufactured by Gish Biomedical, 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 March 30, 2003. Regulation: 8.