SAMS 8000 CARDIOPLEGIA MONITOR
FDA 510(k) clearance K960916 · decided 1996-06-04
Clearance details
- K-number
- K960916
- Device name
- SAMS 8000 CARDIOPLEGIA MONITOR
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1996-03-06
- Decision date
- 1996-06-04
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DSJ
- Device class
- 2
- Regulation number
- 870.1100
- 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 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 42 recall (Z-3214-2011) | Terumo Cardiovascular Systems Corporation | 2011-09-15 |