510(k) K925075

SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR by 3M Health Care, Sarns — Product Code DTZ

K925075 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SARNS TURBO MEMBRANE OXYGENA. W/INT. RESERVOIR". The FDA issued a decision of Substantially Equivalent on June 7, 1993. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.