SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS

SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS is an FDA 510(k)-cleared medical device (K951247) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 1995. Regulation: 8.