Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

About This 510(k) Submission

K172071 is an FDA 510(k) clearance for the Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on March 29, 2018, 262 days after receiving the submission on July 10, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.