FENWAL 40 MICRON TRANSFUSION FILTER— 510(k) K931441

Name: FDA 510(k) clearance K931441
Creator: U.S. Food and Drug Administration
Published: 1993-09-21

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K931441 for FENWAL 40 MICRON TRANSFUSION FILTER, Substantially Equivalent on 1993-09-21. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1993-03-22
Decision date: 1993-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.