CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set— 510(k) K151048

Substantially Equivalent

Bracco Injeneering

FDA 510(k) clearance K151048 for CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set, Substantially Equivalent on 2016-01-22. Applicant: Bracco Injeneering.

Clearance details

Applicant: Bracco Injeneering
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 2015-04-20
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lausanne, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

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.