K991783

Substantially Equivalent

AB-180 XC SYSTEM, MODEL AB-180XC

Applicant: Cardiacassist, Inc.
Product code: KFM
Advisory panel: Cardiovascular
Date received: 1999-05-25
Decision date: 2000-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, 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.