510(k) K071521 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 21, 2007 |
| Received | Jun 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jun 11, 2010 | Terumo Cardiovascular Systems Corporation Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI.
The Terumo HX2 Temperature Management System provides temperature con Terminated |
DWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.