510(k) K941653

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION by 3M Health Care, Sarns — Product Code DTZ

K941653 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION". The FDA issued a decision of Substantially Equivalent on August 24, 1994. 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.