HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
FDA 510(k) clearance K014083 · decided 2002-01-08
Clearance details
- K-number
- K014083
- Device name
- HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
- Applicant
- Haemonetics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-12-11
- Decision date
- 2002-01-08
- Days to decision
- 28 days
- Clearance type
- Special
- 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 Autogolous Blood Recovery System Model Numbr: LN02005-110-E recall (Z-0822-06) | Haemonetics Corporation | 2006-04-29 |
| Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP recall (Z-0823-06) | Haemonetics Corporation | 2006-04-29 |