ClearanceBrief
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)
Get daily alerts for DWCSample briefCSV

Top companies in DWC

DateFirm and productCodeLinked 510(k)
Dec 15, 2023CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Open, Classified
DWCK102147
Dec 15, 2023CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Open, Classified
DWCK102147
Dec 1, 2023CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Open, Classified
DWCK102147
Dec 1, 2023CardioQuip, LLC
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Open, Classified
DWCK102147
Oct 6, 2023LivaNova Deutschland GmbH
3T Heater Cooler System, REF: 16-02-85
Open, Classified
DWCK191402
Oct 6, 2021CardioQuip, LLC
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Open, Classified
DWCK102147
Oct 6, 2021CardioQuip, LLC
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Open, Classified
DWCK102147
Oct 6, 2021CardioQuip, LLC
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Open, Classified
DWCK102147
Oct 6, 2021CardioQuip, LLC
CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Open, Classified
DWCK102147
Jul 14, 2021Maquet 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
DWCK031544
Jun 24, 2021CardioQuip, LLC
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Open, Classified
DWCK102147
Jun 17, 2021Gentherm 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
DWCK122813
Apr 16, 2021Terumo 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
DWCK883603
Apr 16, 2021Terumo 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
DWCK841402
Apr 16, 2021Terumo 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
DWCK071521
Feb 24, 2020LivaNova 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
DWCK052601
Dec 19, 2018Cincinnati 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
DWCK122813
Nov 1, 2018LivaNova 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
DWCK052601
Oct 3, 2018Cincinnati 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
DWCK122813
Sep 14, 2018LivaNova 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
DWCK052601
May 18, 2018LivaNova 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
DWCK052601
Apr 18, 2018Terumo 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
DWCK883603
Apr 18, 2018Terumo Cardiovascular Systems Corporation
Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
Terminated
DWCK841402
Apr 18, 2018Terumo 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
DWCK071521
Feb 13, 2018Cincinnati 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
DWCK122813
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Terminated
DWCK052601
Jul 25, 2017Sorin Group USA, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Terminated
DWCK052601
Mar 9, 2017Cincinnati Sub-Zero Products Inc
Hemotherm CE, model 400CE, Heater-Cooling Device
Terminated
DWCK122813
Dec 1, 2016Sorin 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
DWCK052601
Sep 27, 2016Maquet 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
DWCK031544
Jul 14, 2016Terumo 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
DWCNone listed
Jul 14, 2016Terumo 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
DWCK883603
Jul 14, 2016Terumo 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
DWCK841402
Jul 14, 2016Terumo 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
DWCK071521
Mar 17, 2016Sorin 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
DWCK052601
Jan 5, 2016Maquet 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
DWCK031544
Jul 15, 2015Sorin 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
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Jul 15, 2015Sorin Group USA, Inc.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Terminated
DWCK052601
Feb 13, 2015Terumo 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
DWCK071521
Jun 21, 2013Terumo 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
DWCK883603
Nov 13, 2012Terumo 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
DWCK071521
Nov 13, 2012Terumo 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
DWCK071521

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.