LifeSPARC System— 510(k) K211830

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K211830 for LifeSPARC System, Substantially Equivalent on 2022-11-15. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code QNR
Advisory panel: Cardiovascular
Date received: 2021-06-14
Decision date: 2022-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburg, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QNR

product code QNR

Death: 11
Total: 11

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.