FDA 510(k) Applications for Medical Device Product Code "DWC"
(Controller, Temperature, Cardiopulmonary Bypass)

FDA 510(k) Number Applicant Device Name Decision Date
K883603 3M HEALTH CARE, SARNS SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 11/03/1988
K873813 3M HEALTH CARE, SARNS SARNS WARMER, PART #164975 AND #164980 11/06/1987
K001520 ALPHA OMEGA, INC. ALPHA OMEGA DUAL COOLER-HEATER 11/22/2000
K873924 BUCKMAN CO., INC. PTI HEART-CHILL POUCH/PAD SLING (STERILE) 02/02/1988
K102147 CARDIOQUIP LLP CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 11/19/2010
K122813 CINCINNATI SUB-ZERO PRODUCTS, INC. HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM 12/18/2012
K896972 DAILY MEDICAL PRODUCTS, INC. CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 02/05/1990
K896973 DAILY MEDICAL PRODUCTS, INC. CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 02/05/1990
K896975 DAILY MEDICAL PRODUCTS, INC. CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 02/05/1990
K896974 DAILY MEDICAL PRODUCTS, INC. CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 02/05/1990
K896971 DAILY MEDICAL PRODUCTS, INC. CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 02/05/1990
K896393 DAILY MEDICAL, INC. CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 02/02/1990
K831677 GAMBRO, INC. HYPER-HYPOTHERMIA UNIT HYPO 10-200 07/18/1983
K822874 GAMBRO, INC. THERMOSTATIC WATER MIXING VALVE TWV10 10/18/1982
K031544 JOSTRA AB HEATER COOLER UNIT, MODEL HCU 30 08/07/2003
K945720 JOSTRA BENTLEY JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE 03/29/1995
K130300 MAQUET CARDIOPULMONARY AG HEATER-COOLER UNIT HCU 40 07/01/2013
K014016 MINNTECH CORP. ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER 02/01/2002
K003145 ORIGEN BIOMEDICAL, INC. ORIGEN BLADDER HOLDER 04/20/2001
K874927 PIONEERING TECHNOLOGIES, INC. PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET 01/29/1988
K893940 POLYSTAN C/O VITALCOR, INC. POLYSTAN HEATER-COOLER UNIT 01/18/1990
K841402 SAMS, INC. TEMPERATURE CONTROL & MONITOR 06/11/1984
K873699 SEABROOK MEDICAL SYSTEMS, INC. ECMO-TEMP (TM) BLOOD WARMING DEVICE 12/22/1987
K810647 SHILEY, INC. SHILEY OXYGENATOR THERMISTOR PROBE 04/03/1981
K140012 SORIN GROUP DEUTSCHLAND GMBH SORIN FLEXTHERM 01/31/2014
K052601 SORIN GROUP DEUTSCHLAND GMBH STOCKERT HEATER-COOLER SYSTEM 3T 06/06/2006
K071521 TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM 11/21/2007


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