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
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A Open, Classified |
DWC | K102147 |
| Dec 15, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A Open, Classified |
DWC | K102147 |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A Open, Classified |
DWC | K102147 |
| Dec 1, 2023 | CardioQuip, LLC CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A Open, Classified |
DWC | K102147 |
| Oct 6, 2023 | LivaNova Deutschland GmbH 3T Heater Cooler System, REF: 16-02-85 Open, Classified |
DWC | K191402 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134 Open, Classified |
DWC | K102147 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110 Open, Classified |
DWC | K102147 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127 Open, Classified |
DWC | K102147 |
| Oct 6, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103 Open, Classified |
DWC | K102147 |
| Jul 14, 2021 | Maquet Medical Systems USA Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which pa Terminated |
DWC | K031544 |
| Jun 24, 2021 | CardioQuip, LLC CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices. Open, Classified |
DWC | K102147 |
| Jun 17, 2021 | Gentherm Medical, LLC Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures Terminated |
DWC | K122813 |
| Apr 16, 2021 | Terumo Cardiovascular Systems Corporation The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freez Terminated |
DWC | K883603 |
| Apr 16, 2021 | Terumo Cardiovascular Systems Corporation The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool Terminated |
DWC | K841402 |
| Apr 16, 2021 | Terumo Cardiovascular Systems Corporation The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during car Terminated |
DWC | K071521 |
| Feb 24, 2020 | LivaNova USA Inc. LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures last Terminated |
DWC | K052601 |
| Dec 19, 2018 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE
Product Usage:
The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flow Terminated |
DWC | K122813 |
| Nov 1, 2018 | LivaNova USA Inc. SORIN Heater-Cooler System 3T 120V~/60Hz
REF 16-02-85
Description of product:
The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling syste Terminated |
DWC | K052601 |
| Oct 3, 2018 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Hemotherm 400CE, Catalog Numbers 86022 & 86023
The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat E Terminated |
DWC | K122813 |
| Sep 14, 2018 | LivaNova USA Inc. SORIN Heater-Cooler System 3T, REF 16-02-85
Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extraco Terminated |
DWC | K052601 |
| May 18, 2018 | LivaNova USA Sorin Stockert Heater-Cooler System 3T,
a) Item #: 16-02-81, 240 v/60 Hz;
b) Item #: 16-02-82, 208 v/60 Hz;
c) Item #: 16-02-85, 120 v/60 Hz Terminated |
DWC | K052601 |
| Apr 18, 2018 | Terumo Cardiovascular Systems Corporation Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014
The Sarns TCM is indicated for controlling and monitoring patient temperature . Terminated |
DWC | K883603 |
| Apr 18, 2018 | Terumo Cardiovascular Systems Corporation Sarns TCM, Catalog No. 15747
The Sarns TCM is indicated for controlling and monitoring patient temperature . Terminated |
DWC | K841402 |
| Apr 18, 2018 | Terumo Cardiovascular Systems Corporation Terumo HX2 Temperature Management System, Catalog No. 809810
The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open hea Terminated |
DWC | K071521 |
| Feb 13, 2018 | Cincinnati Sub-Zero Products LLC Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR
Product Usage:
A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The de Terminated |
DWC | K122813 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 120V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 127V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 208V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 240V/60 Hz Terminated |
DWC | K052601 |
| Jul 25, 2017 | Sorin Group USA, Inc. STOCKERT Heater-Cooler System 3T, 230 V Terminated |
DWC | K052601 |
| Mar 9, 2017 | Cincinnati Sub-Zero Products Inc Hemotherm CE, model 400CE, Heater-Cooling Device Terminated |
DWC | K122813 |
| Dec 1, 2016 | Sorin Group USA, Inc. STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz
The Heater Cooler 3T is Terminated |
DWC | K052601 |
| Sep 27, 2016 | Maquet Cardiovascular Us Sales, Llc Heater Cooler Unit
Usage:
The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for b Terminated |
DWC | K031544 |
| Jul 14, 2016 | Terumo Cardiovascular Systems Corporation Preamendments device-Sarns Dual Cooler-Heater.
The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies wat Terminated |
DWC | None listed |
| Jul 14, 2016 | Terumo Cardiovascular Systems Corporation Sarns TCM II;
The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an
extracorporeal circuit and for blanket Terminated |
DWC | K883603 |
| Jul 14, 2016 | Terumo Cardiovascular Systems Corporation Sarns TCM;
The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally Terminated |
DWC | K841402 |
| Jul 14, 2016 | Terumo Cardiovascular Systems Corporation HX2" Temperature Management Systems;
The Terumo HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient bl Terminated |
DWC | K071521 |
| Mar 17, 2016 | Sorin Group USA, Inc. Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259 Terminated |
DWC | K052601 |
| Jan 5, 2016 | Maquet Cardiovascular Us Sales, Llc Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W
Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or coo Terminated |
DWC | K031544 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Jul 15, 2015 | Sorin Group USA, Inc. Sorin Stockert Heater-Cooler 3T, 230 V
Temperature control for extracorporeal perfusion of durations up to 6 hours. Terminated |
DWC | K052601 |
| Feb 13, 2015 | Terumo Cardiovascular Systems Corporation Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiov Terminated |
DWC | K071521 |
| Jun 21, 2013 | Terumo Cardiovascular Systems Corporation Sarns " TCM II Temperature Control Module
The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is i Terminated |
DWC | K883603 |
| Nov 13, 2012 | Terumo Cardiovascular Systems Corporation Tested AC Control BD, 120V, X2
The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorpo Terminated |
DWC | K071521 |
| Nov 13, 2012 | Terumo Cardiovascular Systems Corporation HX2 Temp Manage SYS 120V
The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal c Terminated |
DWC | K071521 |
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