K014083
Substantially EquivalentHAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
- Applicant
- Haemonetics Corp.
- Product code
- CAC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Braintree, 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.