510(k) K180448

INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter by Sorin Group Italia S.R.L. — Product Code DTZ

K180448 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter". The FDA issued a decision of Substantially Equivalent on Mar 15, 2018. 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 60 other 510(k) clearances on record.