MEDRAD Stellant FLEX CT Injection System with Certegra Workstation— 510(k) K192370

Substantially Equivalent

Bayer Medical Care, Inc.

FDA 510(k) clearance K192370 for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, Substantially Equivalent on 2019-12-13. Applicant: Bayer Medical Care, Inc..

Clearance details

Applicant: Bayer Medical Care, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2019-08-30
Decision date: 2019-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.