COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS— 510(k) K881811

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K881811 for COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS, Substantially Equivalent on 1988-09-15. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1988-04-28
Decision date: 1988-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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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.