K221722 is an FDA 510(k) clearance for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US). This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Haemonetics Corporation (Boston, US). The FDA issued a Cleared decision on November 15, 2022, 154 days after receiving the submission on June 14, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K221722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2022 |
| Decision Date | November 15, 2022 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC - Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |