INSUFLOW DEWHEART

INSUFLOW DEWHEART is an FDA 510(k)-cleared medical device (K091366) manufactured by Lexion Medical, LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2009. Regulation: 8.