510(k) K871471— CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15

Substantially Equivalent

Travenol Laboratories, S.A.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1987-04-14
Decision date: 1987-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Lake, IL, US

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.