CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System— 510(k) K222038
Substantially EquivalentAbbott (Formerly Thoratec Corporation)
FDA 510(k) clearance K222038 for CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System, Substantially Equivalent on 2022-12-08. Applicant: Abbott (Formerly Thoratec Corporation).
Clearance details
- Applicant
- Abbott (Formerly Thoratec Corporation)
- Product code
- Code QNR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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.