LOW-ACETATE HEMODIALYSIS BATH CONCENTR.— 510(k) K800624

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K800624 for LOW-ACETATE HEMODIALYSIS BATH CONCENTR., Substantially Equivalent on 1980-07-14. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-19
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

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.