K110845

Substantially Equivalent

IMPELLA CONTROLLER WITH FLOW CONTROL

Applicant: Abiomed, Inc.
Product code: KFM
Advisory panel: Cardiovascular
Date received: 2011-03-28
Decision date: 2011-04-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

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.