CentriMag Acute Circulatory Support System— 510(k) K234118
Substantially EquivalentABBOTT MEDICAL
FDA 510(k) clearance K234118 for CentriMag Acute Circulatory Support System, Substantially Equivalent on 2024-01-26. Applicant: ABBOTT MEDICAL.
Clearance details
- Applicant
- ABBOTT MEDICAL
- Product code
- Code QNR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Adverse events under product code QNR
product code QNR- Death
- 11
- Total
- 11
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.