510(k) K201916

Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator by Sorin Group Italia S.R.L. — Product Code DTZ

K201916 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator". The FDA issued a decision of Substantially Equivalent on August 13, 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.