BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR— 510(k) K073339

Substantially Equivalent

Fenwal, Inc.

FDA 510(k) clearance K073339 for BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR, Substantially Equivalent on 2008-03-03. Applicant: Fenwal, Inc..

Clearance details

Applicant: Fenwal, Inc.
Product code: Code BRZ
Advisory panel: General Hospital
Date received: 2007-11-28
Decision date: 2008-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Zurich, IL, US

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Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.