COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS— 510(k) K864831

Name: FDA 510(k) clearance K864831
Creator: U.S. Food and Drug Administration
Published: 1987-03-27

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K864831 for COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS, Substantially Equivalent on 1987-03-27. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FJI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-09
Decision date: 1987-03-27
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.