510(k) K770937— PUMP, BYPASS, PULSATILE, AVCO

Substantially Equivalent

Avco Medical Products

Clearance details

Applicant: Avco Medical Products
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1977-05-23
Decision date: 1977-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.