GAMBRO G SERIES BLOOD LINE SETS FOR HEM.— 510(k) K801016

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K801016 for GAMBRO G SERIES BLOOD LINE SETS FOR HEM., Substantially Equivalent on 1980-05-30. Applicant: Gambro, Inc..

Clearance details

Applicant: Gambro, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1980-04-29
Decision date: 1980-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.