BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET— 510(k) K905518

Substantially Equivalent

Venusa , Ltd.

FDA 510(k) clearance K905518 for BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET, Substantially Equivalent on 1991-06-21. Applicant: Venusa , Ltd..

Clearance details

Applicant: Venusa , Ltd.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1990-12-07
Decision date: 1991-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.