K111658

Substantially Equivalent

AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

Applicant: Medtronic, Inc.
Product code: KFM
Advisory panel: Cardiovascular
Date received: 2011-06-14
Decision date: 2011-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Mounds View, MN, 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.