510(k) K812697— HEMA 20 MICRON TRANSFUSION BLOOD FILTER

Substantially Equivalent

Abbott Laboratories

Clearance details

Applicant: Abbott Laboratories
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1981-09-22
Decision date: 1981-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.