Haemonetics Corporation · Class II · Cleared Nov 15, 2022
| K-number | K221722 |
| Device name | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) |
| Applicant | Haemonetics Corporation |
| Product code | CAC |
| Device class | Class II |
| Decision date | Nov 15, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 868.5830 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov