FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72— 510(k) K982822

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K982822 for FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72, Substantially Equivalent on 1998-09-30. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1998-08-11
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, 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.