HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R— 510(k) K914790

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K914790 for HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R, Substantially Equivalent on 1993-03-05. Applicant: National Medical Care, Medical Products Div., Inc..

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-23
Decision date: 1993-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, 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.