GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520— 510(k) K100364

Substantially Equivalent

Gambro Renal Products, Inc.

FDA 510(k) clearance K100364 for GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520, Substantially Equivalent on 2010-11-03. Applicant: Gambro Renal Products, Inc..

Clearance details

Applicant: Gambro Renal Products, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2010-02-12
Decision date: 2010-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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.