510(k) K841402 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
TEMPERATURE CONTROL & MONITOR
| Applicant | Sams, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 11, 1984 |
| Received | Apr 3, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K841402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.