510(k) K201320— Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor

Substantially Equivalent

Qura S.R.L

Clearance details

Applicant: Qura S.R.L
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2020-05-18
Decision date: 2021-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

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.