FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile is an FDA 510(k)-cleared medical device (K170029) manufactured by International Biophysics Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2017. Regulation: 8.