LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE— 510(k) K081221
Substantially EquivalentLevitronix, LLC
FDA 510(k) clearance K081221 for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE, Substantially Equivalent on 2008-06-19. Applicant: Levitronix, LLC.
Clearance details
- Applicant
- Levitronix, LLC
- Product code
- Code DWA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Adverse events under product code DWA
product code DWA- Death
- 15
- Malfunction
- 1,654
- Total
- 1,669
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.