Panels › Cardiovascular › Product code DWC · Class 2
Controller, Temperature, Cardiopulmonary Bypass
Regulation 870.4250
0510(k)s in 12 months (30 all time)
0recalls in 12 months (52 all time)
51recalls that name a 510(k)
Top companies in DWC
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2022 | K220635 | Heater-Cooler System 3T Livanova Deutschland, GmbH, DE | DWC |
| May 6, 2022 | K212657 | Quantum Heater-Cooler Spectrum Medical , Ltd., GB | DWC |
| Feb 25, 2020 | K191402 | Heater-Cooler System 3T Livanova Deutschland, GmbH, DE | DWC |
| Jan 31, 2014 | K140012 | SORIN FLEXTHERM Sorin Group Deutschland GmbH | DWC |
| Jul 1, 2013 | K130300 | HEATER-COOLER UNIT HCU 40 Maquet Cardiopulmonary, AG | DWC |
| Dec 18, 2012 | K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc. | DWC |
| Nov 19, 2010 | K102147 | CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 Cardioquip Llp | DWC |
| Nov 21, 2007 | K071521 | TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM Terumo Cardiovascular Systems Corp. | DWC |
| Jun 6, 2006 | K052601 | STOCKERT HEATER-COOLER SYSTEM 3T Sorin Group Deutschland GmbH | DWC |
| Aug 7, 2003 | K031544 | HEATER COOLER UNIT, MODEL HCU 30 Jostra AB | DWC |
| Feb 1, 2002 | K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER Minntech Corp. | DWC |
| Apr 20, 2001 | K003145 | ORIGEN BLADDER HOLDER Origen Biomedical, Inc. | DWC |
| Nov 22, 2000 | K001520 | ALPHA OMEGA DUAL COOLER-HEATER Alpha Omega, Inc. | DWC |
| Mar 29, 1995 | K945720 | JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE Jostra Bentley | DWC |
| Feb 5, 1990 | K896975 | CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 Daily Medical Products, Inc. | DWC |
| Feb 5, 1990 | K896974 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 Daily Medical Products, Inc. | DWC |
| Feb 5, 1990 | K896973 | CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 Daily Medical Products, Inc. | DWC |
| Feb 5, 1990 | K896972 | CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 Daily Medical Products, Inc. | DWC |
| Feb 5, 1990 | K896971 | CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 Daily Medical Products, Inc. | DWC |
| Feb 2, 1990 | K896393 | CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 Daily Medical, Inc. | DWC |
| Jan 18, 1990 | K893940 | POLYSTAN HEATER-COOLER UNIT Polystan C/O Vitalcor, Inc., DK | DWC |
| Nov 3, 1988 | K883603 | SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) 3M Health Care, Sarns | DWC |
| Feb 2, 1988 | K873924 | PTI HEART-CHILL POUCH/PAD SLING (STERILE) Buckman Co., Inc. | DWC |
| Jan 29, 1988 | K874927 | PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET Pioneering Technologies, Inc. | DWC |
| Dec 22, 1987 | K873699 | ECMO-TEMP (TM) BLOOD WARMING DEVICE Seabrook Medical Systems, Inc. | DWC |
| Nov 6, 1987 | K873813 | SARNS WARMER, PART #164975 AND #164980 3M Health Care, Sarns | DWC |
| Jun 11, 1984 | K841402 | TEMPERATURE CONTROL & MONITOR Sams, Inc. | DWC |
| Jul 18, 1983 | K831677 | HYPER-HYPOTHERMIA UNIT HYPO 10-200 Gambro, Inc. | DWC |
| Oct 18, 1982 | K822874 | THERMOSTATIC WATER MIXING VALVE TWV10 Gambro, Inc. | DWC |
| Apr 3, 1981 | K810647 | SHILEY OXYGENATOR THERMISTOR PROBE Shiley, Inc. | DWC |
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