510(k) K172071

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) by Terumo Cardiovascular Systems Corporation — Product Code DTZ

K172071 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "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)". The FDA issued a decision of Substantially Equivalent on March 29, 2018. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.