Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)— 510(k) K221722
Substantially EquivalentHaemonetics Corporation
FDA 510(k) clearance K221722 for Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US), Substantially Equivalent on 2022-11-15. Applicant: Haemonetics Corporation.
Clearance details
- Applicant
- Haemonetics Corporation
- Product code
- Code CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.