Revolution Centrifugal Blood Pump— 510(k) K190650

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K190650 for Revolution Centrifugal Blood Pump, Substantially Equivalent on 2019-08-07. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2019-03-13
Decision date: 2019-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

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.