510(k) K200683

INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir by Sorin Group Italia S.R.L. — Product Code DTZ

K200683 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir". The FDA issued a decision of Substantially Equivalent on June 12, 2020. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.