Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor— 510(k) K191077

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K191077 for Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor, Substantially Equivalent on 2019-08-27. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2019-04-23
Decision date: 2019-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.