GAMBRO LUNDIA 94-500 DIALYZER— 510(k) K945746

Substantially Equivalent

Cobe Renal Care, Inc.

FDA 510(k) clearance K945746 for GAMBRO LUNDIA 94-500 DIALYZER, Substantially Equivalent on 1995-09-08. Applicant: Cobe Renal Care, Inc..

Clearance details

Applicant: Cobe Renal Care, Inc.
Product code: Code FJI
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-23
Decision date: 1995-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, 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.