POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR— 510(k) K043342

Name: FDA 510(k) clearance K043342
Creator: U.S. Food and Drug Administration
Published: 2005-05-27

Substantially Equivalent

Gambro Renal Products

FDA 510(k) clearance K043342 for POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR, Substantially Equivalent on 2005-05-27. Applicant: Gambro Renal Products. Device class: 2.

Clearance details

Applicant: Gambro Renal Products
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2004-12-06
Decision date: 2005-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FJI

product code FJI

Death: 2
Total: 2

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.