MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY— 510(k) K063090

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K063090 for MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY, Substantially Equivalent on 2007-03-27. Applicant: Medrad, Inc..

Clearance details

Applicant: Medrad, Inc.
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 2006-10-10
Decision date: 2007-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianola, PA, US

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.