AFFIITY CP CENTRIFUGAL BLOOD PUMP— 510(k) K100631

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K100631 for AFFIITY CP CENTRIFUGAL BLOOD PUMP, Substantially Equivalent on 2010-06-22. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2010-03-05
Decision date: 2010-06-22
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.