FENWAL 40 MICRON TRANSFUSION FILTER— 510(k) K972159

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K972159 for FENWAL 40 MICRON TRANSFUSION FILTER, Substantially Equivalent on 1997-07-23. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1997-06-09
Decision date: 1997-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

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.