SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
FDA 510(k) clearance K883603 · decided 1988-11-03
Clearance details
- K-number
- K883603
- Device name
- SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1988-08-23
- Decision date
- 1988-11-03
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 recall (Z-1418-2018) | Terumo Cardiovascular Systems Corporation | 2018-04-18 |
| Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source recall (Z-2209-2016) | Terumo Cardiovascular Systems Corporation | 2016-07-14 |
| Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is recall (Z-1569-2013) | Terumo Cardiovascular Systems Corporation | 2013-06-21 |