510(k) K190690

INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir by Sorin Group Italia S.R.L. — Product Code DTZ

K190690 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir". The FDA issued a decision of Substantially Equivalent on April 13, 2019. 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.