CELL SAVER 5 SYSTEM
FDA 510(k) clearance K932890 · decided 1994-01-05
Clearance details
- K-number
- K932890
- Device name
- CELL SAVER 5 SYSTEM
- Applicant
- Haemonetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-14
- Decision date
- 1994-01-05
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Braintree, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Haemonetics Cell Saver 5 Fast Pack List Number: 260 recall (Z-0498-03) | Haemonetics Corporation | 2003-01-30 |
| Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir List Number: 260F recall (Z-0499-03) | Haemonetics Corporation | 2003-01-30 |
| Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261 recall (Z-0500-03) | Haemonetics Corporation | 2003-01-30 |
| Haemonetics High Speed Cell Saver Bowl Set List Number: 263 recall (Z-0501-03) | Haemonetics Corporation | 2003-01-30 |
| Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack List Number: 265 recall (Z-0502-03) | Haemonetics Corporation | 2003-01-30 |
| Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: recall (Z-0503-03) | Haemonetics Corporation | 2003-01-30 |