ST FAMILY OF HOLLOW FIBER DIALYZERS— 510(k) K844756

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K844756 for ST FAMILY OF HOLLOW FIBER DIALYZERS, Substantially Equivalent on 1985-01-16. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1984-12-05
Decision date: 1985-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.