510(k) K122813 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Dec 18, 2012 |
| Received | Sep 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Mar 9, 2017 | Cincinnati Sub-Zero Products Inc Hemotherm CE, model 400CE, Heater-Cooling Device Terminated |
DWC | None listed |
| Nov 22, 2016 | Cincinnati Sub-Zero Products Inc The Hemotherm 400CE 115v, containing power board p/n 39945 Terminated |
DWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.