510(k) K883603 ยท DWC Controller, Temperature, Cardiopulmonary Bypass
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
| Applicant | 3M Health Care, Sarns, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 3, 1988 |
| Received | Aug 23, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.