FENWAL 40 MICRON TRANSFUSION FILTER— 510(k) K931441

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.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code FPB
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 ↗

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.