GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER— 510(k) K900918

Name: FDA 510(k) clearance K900918
Creator: U.S. Food and Drug Administration
Published: 1990-07-16

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K900918 for GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER, Substantially Equivalent on 1990-07-16. Applicant: Gambro, Inc.. Device class: 2.

Clearance details

Applicant: Gambro, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-27
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.