BYS — Oxygenator, Long Term Support Greater Than 6 Hours Class II

FDA Device Classification

FDA product code BYS covers "Oxygenator, Long Term Support Greater Than 6 Hours", a Class II medical device regulated under 21 CFR 870.4100. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.