HEMA - NV TRANS. BLOOD FILTER 100/800— 510(k) K830014

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K830014 for HEMA - NV TRANS. BLOOD FILTER 100/800, Substantially Equivalent on 1983-01-17. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1983-01-03
Decision date: 1983-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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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.