RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D.— 510(k) K801825

Substantially Equivalent

Renal Systems, Inc.

FDA 510(k) clearance K801825 for RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D., Substantially Equivalent on 1980-09-26. Applicant: Renal Systems, Inc..

Clearance details

Applicant: Renal Systems, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1980-07-31
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.