510(k) K170029

FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile by International Biophysics Corporation — Product Code KFM

K170029 is an FDA 510(k) premarket notification submitted by International Biophysics Corporation for the device "FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile". The FDA issued a decision of Substantially Equivalent on December 15, 2017. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. International Biophysics Corporation has at least 2 other 510(k) clearances on record.