LifeSPARC Pump, LifeSPARC Controller— 510(k) K183623

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K183623 for LifeSPARC Pump, LifeSPARC Controller, Substantially Equivalent on 2019-07-09. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.