RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS— 510(k) K883748

Substantially Equivalent

Kawasumi Laboratories Co., Ltd.

FDA 510(k) clearance K883748 for RENAK-E & RENEK-A SERIES HOLLOW FIBER DIALYZERS, Substantially Equivalent on 1989-01-31. Applicant: Kawasumi Laboratories Co., Ltd..

Clearance details

Applicant: Kawasumi Laboratories Co., Ltd.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1988-09-01
Decision date: 1989-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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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.