IMPELLA CONTROLLER— 510(k) K093801

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K093801 for IMPELLA CONTROLLER, Substantially Equivalent on 2010-07-08. Applicant: Abiomed, Inc..

Clearance details

Applicant: Abiomed, Inc.
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2009-12-10
Decision date: 2010-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, 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.