LifeSPARC System— 510(k) K233736
Substantially EquivalentCardiacassist, Inc.
FDA 510(k) clearance K233736 for LifeSPARC System, Substantially Equivalent on 2024-01-19. Applicant: Cardiacassist, Inc..
Clearance details
- Applicant
- Cardiacassist, Inc.
- Product code
- Code QNR
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, 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.