FDA 510(k) Applications for Medical Device Product Code "DTX"
(Gas Control Unit, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K863902 3M HEALTH CARE, SARNS MODIFIED SARNS MEMBRANE OXYGENATOR 12/11/1986
K790546 COBE LABORATORIES, INC. FLOWMETER, OPTIFLO GAS 05/11/1979
K965214 COEUR LABORATORIES, INC. COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) 03/28/1997
K792348 CORDIS CORP. STANICOR, OMNI-STAN,MOD 333B,334A GAMMA 12/05/1979
K822820 GAMBRO, INC. GAS-FLOW METER GFL 10 10/18/1982
K101046 SORIN GROUP DEUTSCHLAND GMBH STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM 12/09/2010


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