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
(FDA 510(k) Clearance)

K180448 is an FDA 510(k) clearance for the 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, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on March 15, 2018, 30 days after receiving the submission on February 13, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.